biosimilar

In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve biosimilars to those biologics originally approved through the PHS Act pathway.{{cite web|url=http://judiciary.senate.gov/testimony.cfm?id=1239&wit_id=3623|title=US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004|access-date=October 8, 2007|archive-url=https://web.archive.org/web/20161228003407/http://www.judiciary.senate.gov/testimony.cfm?id=1239&wit_id=3623|archive-date=December 28, 2016|url-status=dead}} Additional Congressional hearings have been held.[http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.050207.Biosimilar.shtml Hearing: Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007] {{webarchive |url=https://web.archive.org/web/20070922194116/http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.050207.Biosimilar.shtml |date=September 22, 2007 }} On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House.{{cite journal |author=Nick, C |title=The US Biosimilars Act: Challenges Facing Regulatory Approval|journal=Pharm Med |volume=26 |issue=3 |pages=145–152 |year=2012 |doi=10.1007/bf03262388|s2cid=14604362}} Since 2004 the FDA has held a series of public meetings on biosimilars.{{cite web|url=https://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm085854.htm|archive-url=https://web.archive.org/web/20090709214850/http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm085854.htm|url-status=dead|archive-date=July 9, 2009|title=FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing"|website=U.S. Food and Drug Administration (FDA)}}{{cite web|url=https://www.fda.gov/Drugs/NewsEvents/ucm221688.htm|archive-url=https://web.archive.org/web/20101007165215/http://www.fda.gov/Drugs/NewsEvents/ucm221688.htm|url-status=dead|archive-date=October 7, 2010|title=FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting"|website=U.S. Food and Drug Administration (FDA)}}

The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010.{{citation needed|date=December 2019}}

The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin, originally approved as a biologic under the FD&C Act.{{cite web|url=https://www.fda.gov/ohrms/dockets/dockets/04P0231/04P-0231-pdn0001.pdf|title=FDA Response to three Citizen Petitions against biosimilars|website=U.S. Food and Drug Administration (FDA)|access-date=December 16, 2019|archive-date=May 31, 2017|archive-url=https://web.archive.org/web/20170531010155/https://www.fda.gov/ohrms/dockets/dockets/04p0231/04p-0231-pdn0001.pdf|url-status=dead}}

On March 6, 2015, Zarxio obtained the first approval of FDA.{{cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm|archive-url=https://web.archive.org/web/20150307142645/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm|url-status=dead|archive-date=March 7, 2015|title=FDA page on "FDA approves first biosimilar product Zarxio"|website=U.S. Food and Drug Administration (FDA)}} Sandoz's Zarxio is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen.{{citation needed|date=December 2021}}

In March 2020, most protein products that were approved as drug products (including every insulin currently on the market {{as of|December 2019|lc=yes}}) are scheduled to open up to biosimilar and interchangeable competition in the United States.{{cite web | title=Statement on low-cost biosimilar and interchangeable protein products | website=U.S. Food and Drug Administration (FDA) | date=December 17, 2019 | url=https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products | archive-url=https://web.archive.org/web/20191218020741/https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products | archive-date=December 18, 2019 | url-status=dead | access-date=December 17, 2019}} {{PD-notice}} However, "chemically synthesized polypeptides" are excluded from this transition, which means that a product that falls within this category won't be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway.

Cloning of human genetic material and development of in vitro biological production systems has allowed the production of virtually any recombinant DNA based biological substance for eventual development of a drug. Monoclonal antibody technology combined with recombinant DNA technology has paved the way for tailor-made and targeted medicines. Gene- and cell-based therapies are emerging as new approaches.

Recombinant therapeutic proteins are of a complex nature (composed of a long chain of amino acids, modified amino acids, derivatized by sugar moieties, folded by complex mechanisms). These proteins are made in living cells (bacteria, yeast, animal or human cell lines). The ultimate characteristics of a drug containing a recombinant therapeutic protein are to a large part determined by the process through which they are produced: choice of the cell type, development of the genetically modified cell for production, production process, purification process, formulation of the therapeutic protein into a drug.

After the expiry of the patent of approved recombinant drugs (e.g., insulin, human growth hormone, interferons, erythropoietin, monoclonal antibodies and more) any other biotech company can develop and market these biologics (thus called biosimilars).

The typical reference product has undergone numerous changes in its manufacturing processes, and such changes in the manufacturing process (ranging from a change in the supplier of cell culture media to new purification methods or new manufacturing sites) was substantiated with appropriate data and was approved by the EMA.

The current concept of development of biosimilar monoclonal antibodies follows the principle that an extensive state of the art physicochemical, analytical and functional comparison of the molecules is complemented by comparative non-clinical and clinical data that establish equivalent efficacy and safety in a clinical "model" indication that is most sensitive to detect any minor differences (if these exist) between the biosimilar and its reference monoclonal antibody also at the clinical level.

The EMA has recognized this fact, which has resulted in the establishment of the term "biosimilar" in recognition that, whilst biosimilar products are similar to the original product, they are not exactly the same.[http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf EMEA guideline on similar biological medicinal products] {{webarchive |url=https://web.archive.org/web/20070630132050/http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf |date=June 30, 2007 }}

Originally the complexity of biological molecules led to requests for substantial efficacy and safety data for a biosimilar approval. This has been progressively replaced with a greater dependence on assays, from quality through to clinical, that show assay sensitivity sufficient to detect any significant difference in dose.{{cite journal | vauthors = Warren JB | title = Generics, chemisimilars and biosimilars: is clinical testing fit for purpose? | journal = British Journal of Clinical Pharmacology | volume = 75 | issue = 1 | pages = 7–14 | date = January 2013 | pmid = 22574725 | pmc = 3555041 | doi = 10.1111/j.1365-2125.2012.04323.x }} However, the safe application of biologics depends on an informed and appropriate use by healthcare professionals and patients. Introduction of biosimilars also requires a specifically designed pharmacovigilance plan. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified. In contrast, small molecule drugs made up of a chemically based compound can be easily replicated and are considerably less expensive to reproduce. In order to be released to the public, biosimilars must be shown to be as close to identical to the parent innovator biologic product based on data compiled through clinical, animal, analytical studies and conformational status.{{cite journal|url = http://www.bioprocessintl.com/manufacturing/biosimilars/higher-order-structure-comparability/|title = Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies| vauthors = Wang X |date = June 1, 2014|journal = BioProcess International|issue = 6|volume = 12|pages = 32–37|access-date = August 13, 2014|archive-date = January 19, 2021|archive-url = https://web.archive.org/web/20210119031453/https://bioprocessintl.com/manufacturing/biosimilars/higher-order-structure-comparability/|url-status = live}}{{cite journal | vauthors = Declerck PJ | title = Biosimilar monoclonal antibodies: a science-based regulatory challenge | journal = Expert Opinion on Biological Therapy | volume = 13 | issue = 2 | pages = 153–6 | date = February 2013 | pmid = 23286777 | doi = 10.1517/14712598.2012.758710 | doi-access = free }}

Generally, once a drug is released in the market by the FDA, it has to be re-evaluated for its safety and efficacy once every six months for the first and second years. Afterward, re-evaluations are conducted yearly, and the result of the assessment should be reported to authorities such as FDA. Biosimilars are required to undergo pharmacovigilance (PVG) regulations as its reference product. Thus biosimilars approved by the EMA are required to submit a risk management plan (RMP) along with the marketing application and have to provide regular safety update reports after the product is in the market. The RMP includes the safety profile of the drug and proposes the prospective pharmacovigilance studies.

Several PK studies, such as studies conducted by Committee for Medicinal Products for Human Use (CHMP), have been conducted under various ranges of conditions; Antibodies from an originator's product versus antibodies from a biosimilar; combination therapy and monotherapy; various diseases, etc. on the purpose to verify comparability in pharmacokinetics of the biosimilar with the reference medicinal product in a sufficiently sensitive and homogeneous population.

In the European Union, no unique identifier of a biosimilar medicine product is required, as the same rules are followed as for all biologics.{{citation needed|date=December 2021}}

The US decided on a different approach, requiring the assignment of a four-letter suffix to the nonproprietary name of the original product to distinguish between innovator drugs and their biosimilars.{{cite web|title = Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability|url = https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-update-guidance-industry|website = U.S. Food and Drug Administration (FDA)|access-date = August 2, 2018|archive-date = September 6, 2019|archive-url = https://web.archive.org/web/20190906175831/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-update-guidance-industry|url-status = dead}} Japan has similar requirements.{{cite journal | vauthors = Velásquez G |title=The International Debate on Generic Medicines of Biological Origin |journal=South Centre Policy Brief |date=August 2018 |issue=50 |url=https://www.southcentre.int/wp-content/uploads/2018/08/PB50_The-International-Debate-on-Generic-Medicines-of-Biological-Origin_EN.pdf |access-date=December 23, 2020 |archive-date=March 6, 2021 |archive-url=https://web.archive.org/web/20210306134448/https://www.southcentre.int/wp-content/uploads/2018/08/PB50_The-International-Debate-on-Generic-Medicines-of-Biological-Origin_EN.pdf |url-status=live }} The suffix approach has been criticized on the grounds of compromising the INN system and delaying the marketing of biosimilars. Australia decided not to use a 4-letter suffix.{{cite web | title=Australian Government Announces Decision on Biosimilar Naming Conventions | website=The Center For Biosimilars | date=January 31, 2018 | url=https://www.centerforbiosimilars.com/view/australian-government-announces-decision-on-biosimilar-naming-conventions | access-date=December 20, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230065202/https://www.centerforbiosimilars.com/view/australian-government-announces-decision-on-biosimilar-naming-conventions | url-status=live }}{{cite web | title=Biosimilar medicines regulation | website=Therapeutic Goods Administration (TGA) | date=April 4, 2018 | url=https://www.tga.gov.au/publication/biosimilar-medicines-regulation | access-date=December 29, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230065216/https://www.tga.gov.au/publication/biosimilar-medicines-regulation | url-status=live }}{{cite web | title=Which biosimilar medicines are available in Australia? | url=https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | access-date=December 29, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230035404/https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | url-status=live }}

A version of the four-letter suffix has been proposed to the WHO as the biological qualifier (BQ). It is not part of the international nonproprietary name (INN), but is proposed to be managed under the same registry.{{cite web |title=Biological Qualifier |url=https://www.who.int/medicines/services/inn/inn_bio_bq/en/ |archive-url=https://web.archive.org/web/20150328123904/http://www.who.int/medicines/services/inn/inn_bio_bq/en/ |url-status=dead |archive-date=March 28, 2015 |website=WHO}} The report 1 of the May 2017 WHO Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products, published in October 2017, revealed on page 4, that following the outcome arising from the meeting: "No consensus was reached on whether WHO should continue with the BQ... WHO will not be proceeding with this at present."{{cite web|title = WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products|url = https://www.who.int/medicines/access/biotherapeutics/FINAL_Report-improving-access-to-and-use-of-biotherapeutics_October2017.pdf|access-date = August 2, 2019|archive-date = October 31, 2017|archive-url = https://web.archive.org/web/20171031162408/http://www.who.int/medicines/access/biotherapeutics/FINAL_Report-improving-access-to-and-use-of-biotherapeutics_October2017.pdf|url-status = live}}

Different from biosimilars, many new antibodies are being developed with the goal to be structurally different (to not violate patents) but functionally very similar to their reference drugs. Similarly, in advanced therapy medicinal products, such as Chimeric Antigen Receptor T-cell (CAR-T) therapy, the exchange of one component by a similar component (e.g. one promoter by another to drive CAR expression), generates structurally different, but functionally similar copies of drugs. There is no established term for such biologics, but the terms "bioparallels" or "me-too biologics" (in reference to me-too drugs) have been proposed.{{Citation | year=2023 | title=Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and Bioparallels | url=https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-not-all-quiet-on-the-biologics-front-biosimilars-biobetters-and-bioparallels | access-date=8 March 2025}}{{cite journal | vauthors=((Ivica, N. A.)), ((Young, C. M.)) | journal=Healthcare | title=Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020) | volume=9 | issue=8 | pages=1062 | date=19 August 2021 | issn=2227-9032 | doi=10.3390/healthcare9081062| doi-access=free | pmid=34442199 | pmc=8392279 }} Within the current frameworks of the US and EU approval processes, these drugs require evaluation as new biological entities. Bioparallels compete with their reference medicines on price but have the advantage of being able to enter the market earlier.

The term "biobetter" refers to a biological drug that is an improved version of an existing biological drug. Unlike biosimilars, the term “biobetter” is used informally without any official and universally accepted definition. While biosimilars try to copy an existing biological drug (the "reference medicine") as closely as possible,{{Citation | year=2017 | title=Biosimilar medicines: Overview | publisher= European Medicines Agency (EMA) | url=https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview | access-date=8 March 2025}}{{Citation | year=2023 | title=Biosimilars | publisher=FDA | url=https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars | archive-url=https://web.archive.org/web/20190602011239/https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars | url-status=dead | archive-date=June 2, 2019 | access-date=10 March 2025}} biobetters try to improve on it.{{cite journal | vauthors=((Sharma, A.)), ((Kumar, N.)), ((Kuppermann, B. D.)), ((Francesco, B.)), ((Loewenstein, A.)) | journal=Eye | title=Biologics, biosilimars, and biobetters: different terms or different drugs? | volume=33 | issue=7 | pages=1032–1034 | date= July 2019 | issn=0950-222X | doi=10.1038/s41433-019-0391-5| pmc=6707288 }} Since the term biobetter is informal, there is no rule which regulatory pathway they need to go through to be approved. When the improvement to the original drug is merely in the formulation (thus, e.g., adding additional modes of administration), the drug might be regulated as a biosimilar. However, if the active pharmaceutical ingredient (API) has been modified, the drug needs to be evaluated as a new biological entity. Even without changes to the API, the biobetter needs to be evaluated as a new biological entity (requiring a biologics license application), if it shows better clinical outcomes compared to the reference medicine. The latter happened e.g. to Zymfentra, an antibody biosimilar that can be given subcutaneously, whereas its reference medicine infliximab was only approved for intravenous administration.{{Citation | year=2023 | title=Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and Bioparallels | url=https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-not-all-quiet-on-the-biologics-front-biosimilars-biobetters-and-bioparallels | access-date=8 March 2025}} Biobetters compete in the market based on their improved features, and are thus different from bioparallels, which compete on price, and which imitate the functionality of a reference medicine as closely as possible, but without violating the associated intellectual property.

Biosimilars available in Australia include adalimumab, bevacizumab, enoxaparin, epoetin lambda, etanercept, filgrastim, follitropin alfa, infliximab, insulin aspart, insulin glargine, pegfilgrastim, rituximab, teriparatide, and trastuzumab.{{cite web | url=https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | title=Which biosimilar medicines are available in Australia? | access-date=December 30, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230035404/https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | url-status=live }}

A research article about "Maximizing the benefits of using biosimilars in Egypt" proposed a regulatory framework for biosimilars in Egypt. The article summarized the recommendations of a number of stakeholders.{{cite journal | vauthors = Fasseeh AN, Elezbawy B, El-Fass KA, GamaI M, Seyam A, Hayek N, Abdel Rahman N, Abdelhamid S, Fasseeh N, Saad AS, Elagamy A, Mahmoud A, Sedrak AS, Elshazly K, Eldebeiky M, Talaat M, Mohamed NM, Abdelaziz RA, Refaat R, Akeel S, Abaza S, Kaló Z | title = Maximizing the benefits of using biosimilars in Egypt | journal = Journal of Pharmaceutical Policy and Practice | volume = 16 | issue = 1 | pages = 79 | date = June 2023 | pmid = 37365620 | pmc = 10291771 | doi = 10.1186/s40545-023-00581-w | doi-access = free }}

;Key Findings and Recommendations of the article

1. Pricing: The experts suggested a mandatory discount of 30–40% on the price of the first biosimilar compared to its originator, with subsequent biosimilars receiving additional discounts. It was also recommended that biosimilar prices be revised periodically, either annually or biennially.
2. Reimbursement: A significant emphasis was placed on using Health Technology Assessment (HTA), specifically cost-effectiveness analysis (CEA) and budget impact analysis (BIA), when manufacturers seek to extend reimbursement indications beyond those of the originator. Additionally, experts proposed that the first biosimilar, offering a minimum 50% discount compared to the originator, be granted immunity from removal from the formulary for a specified period.
3. Uptake: The study highlighted the need for policies that enhance both prescriber and patient acceptance of biosimilars. Strategies include disseminating educational materials, implementing financial incentives for prescribing biosimilars as first-line therapy, and using co-payments to encourage the choice of less expensive biosimilars over more costly biologics.
4. Post-Marketing and Pharmacovigilance: The importance of establishing registries and conducting real-world evidence studies to monitor biosimilar efficacy and safety was also emphasized. A pharmacovigilance framework specific to biosimilars and biologics was suggested to be more effective than the existing general framework.

Biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.{{cite press release | title=Biosimilar medicines can be interchanged | website=European Medicines Agency (EMA) | date=September 19, 2022 | url=https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged | access-date=September 19, 2022 | archive-date=September 20, 2022 | archive-url=https://web.archive.org/web/20220920045913/https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged | url-status=live }}

As of October 2024, the US FDA has approved 60 biosimilars.{{cite press release | title=FDA Roundup: October 4, 2024 | website=U.S. Food and Drug Administration (FDA) | date=4 October 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-october-4-2024 | archive-url=https://web.archive.org/web/20241004200952/https://www.fda.gov/news-events/press-announcements/fda-roundup-october-4-2024 | url-status=dead | archive-date=October 4, 2024 | access-date=8 October 2024}}

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by Senator Edward Kennedy (D-MA). It was formally passed under the Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a Food and Drug Administration (FDA) approved biological product.{{cite web | title=Biosimilars | website=U.S. Food and Drug Administration | date=July 27, 2021 | url=https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars | access-date=August 28, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828185757/https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars | url-status=live }} {{PD-notice}} The BPCI Act is similar, conceptually, to the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The FDA has released a total of four draft guidelines related to biosimilar or follow-on biologics development. Upon the release of the first three guidance documents the FDA held a public hearing on May 11, 2012.{{cite journal | vauthors = Epstein MS, Ehrenpreis ED, Kulkarni PM | title = Biosimilars: the need, the challenge, the future: the FDA perspective | journal = The American Journal of Gastroenterology | volume = 109 | issue = 12 | pages = 1856–9 | date = December 2014 | pmid = 24957160 | doi = 10.1038/ajg.2014.151 | s2cid = 19274464 | url = http://gi.org/wp-content/uploads/2015/01/FDA_Biosimilars_December_2014.pdf | access-date = September 25, 2016 | archive-url = https://web.archive.org/web/20161006151227/http://gi.org/wp-content/uploads/2015/01/FDA_Biosimilars_December_2014.pdf | archive-date = October 6, 2016 | url-status = dead }}

In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for evergreening and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.{{cite press release|url=https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-actions-advancing-agencys-biosimilars-policy|title=Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework|website=U.S. Food and Drug Administration (FDA)|date=December 11, 2018|access-date=December 16, 2018|archive-date=May 8, 2019|archive-url=https://web.archive.org/web/20190508131837/https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-actions-advancing-agencys-biosimilars-policy|url-status=dead}}

• Biobetter

{{Reflist}}

• {{cite journal | vauthors = Udpa N, Million RP | title = Monoclonal antibody biosimilars | journal = Nature Reviews. Drug Discovery | volume = 15 | issue = 1 | pages = 13–4 | date = January 2016 | pmid = 26678619 | doi = 10.1038/nrd.2015.12 | s2cid = 27954836 }}
• {{cite journal | vauthors = Jelkmann W | title = Biosimilar epoetins and other "follow-on" biologics: update on the European experiences | journal = American Journal of Hematology | volume = 85 | issue = 10 | pages = 771–80 | date = October 2010 | pmid = 20706990 | doi = 10.1002/ajh.21805 | s2cid = 205293428 | url = https://hal.archives-ouvertes.fr/hal-00552331/document | doi-access = free }}

• [https://www.fda.gov/media/151058/download Overview of Biosimilar Products] U.S. Food and Drug Administration
• [https://web.archive.org/web/20210729050919/https://www.fda.gov/media/151061/download Biosimilar Regulatory Review and Approval ] U.S. Food and Drug Administration
• [https://www.fda.gov/media/151094/download Interchangeable Biological Products ] U.S. Food and Drug Administration

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