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Biosimilars approved in the US Posted 14/08/2015

Last update: 9 June 2017

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a US Food and Drug Administration (FDA)-licensed biological product.

FDA is still in the process of developing guidelines regarding these types of products and has issued several guidance documents on the subject [1].

Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015 [2]. To date, FDA has approved four biosimilars within the product classes of anti-tumour necrosis factor-alpha (TNF-α) and granulocyte colony-stimulating factor, and a follow-on biological in the product class of insulin for use in the US, see Table 1.

Table 1: FDA approved biosimilars and follow-on biologicals*

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/ Company name

Amjevita (adalimumab-atto)

adalimumab

Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

23 Sep 2016

Amgen

Basaglar#

insulin glargine

Diabetes

16 Dec 2015

Eli Lilly/Boehringer Ingelheim

Epoetin Hospira

epoetin alfa

Anaemia (chronic kidney disease, Zidovudine, chemotherapy)
Reduction of allogeneic red blood cell transfusions

Recommended for approval by FDA’s Oncologic Drugs Advisory Committee (ODAC) on 25 May 2017

Pfizer (Hospira)

Erelzi (etanercept-szzs)

etanercept

Axial spondyloarthritis
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis

30 Aug 2016

Sandoz

Inflectra
(infliximab- dyyb)

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

5 Apr 2016

Pfizer (Hospira)

Renflexis (infliximab-abda)

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

21 Apr 2017

Samsung Bioepis

Zarxio
(filgrastim-sndz)

filgrastim

Autologous peripheral blood progenitor cell collection and therapy
Bone marrow transplantation
Cancer
Myeloid leukaemia
Neutropenia

6 Mar 2015

Sandoz

*Data collected on 30 September 2016, updated 9 June 2017
#Basaglar was approved via an abbreviated pathway, however, no insulin glargine products are currently licensed under the Public Health Service Act, so there is no ‘reference product’ for a proposed biosimilar product.
Source: US FDA 

The landmark decision by FDA to approve its first biosimilar came in the wake of a unanimous vote two months earlier by FDA advisors who recommended approval of Zarxio [3]. Sandoz, the generics division of Novartis, already markets its biosimilar filgrastim product under the brand name Zarzio in more than 40 countries outside the US [4].

Zarxio has been approved as a biosimilar, not as an interchangeable product. According to the BPCI Act, only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

FDA has also designated placeholder non-proprietary names for Amjevita, Erelzi, Inflectra and Zarxio – adalimumab-atto, etanercept-szzs, infliximab-dyyb and filgrastim-sndz, respectively. The agency has, however, made it clear that it has not yet made a final decision on whether biosimilars will receive the same International Nonproprietary Name (INN) as their reference biologicals or unique names.

Related articles
Biosimilars approved in Europe

US guidelines for biosimilars

References
1.   GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars
2.   GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
3.   GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-filgrastim-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application

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Source: US FDA

Comments (3)

Response to ‘Biosimilars’ posted 18/03/2016 posted 05/10/2016 - by Louis B, GaBI Online Editorial Office

Dear Kauntay Parekh, thank you for your valid and interesting comment on this article. Thank you for sharing your thoughts on this subject. We would be delighted if you would consider submitting a short Commentary paper on this topic to GaBI Journal. Please feel free to reach us at editorial@gabi-journal.net for further information. Thank you again and we hope to hear from you soon. Best regards, Louis.

Biosimilars posted 05/10/2016 - by Kauntay Parekh

Hi, Hemanth Kumar, 1. How many phase I, II, III trials are needed to be conducted for a Biosimilar in US and EU? Ans: In US and EU, biosimilar applicant has to discuss with drug regulatory authority to decide the clinical trial (CT) pathway for the particular product (For US FDA and for EU EMA). These regulatory authority devise the CT pathway based on the products similarity with reference biologic (Based on analytical data). Overall, the more similar the biosimilar product to reference product based on analytical data, the lesser CT will be required. 2. What is the trial duration for these trials (In general)? Ans: Trial duration varies from product to product but generally these trials get completed within 2-4 years. 3. How the development timelines and trial size differ for biosimilars from their reference biologic drugs? Ans: Unlike reference product sponsor, biosimilar applicant has to prove similarity, efficacy, safety and toxicity data comparable to reference biologic. Hence, the CT size required for biosimilar is smaller than the reference biologic.

Biosimilars posted 02/09/2015 - by Hemanth Kumar G

Dear Sir/Madam, Thank you very much for your articles and news about Biosimilars and generics world at gabionline. I observed from one of your articles that it takes less than 2 years for completion of Biosimilar pivotal trials, I have a few queries regarding that. 1. How many phase I, II, III trials are needed to be conducted for a Biosimilar in US and EU? 2. What is the trial duration for these trials (In general) ? 3. How the development timelines and trial size differ for Biosimilars from their reference biologic drugs? I would be grateful if you can answer these queries