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Uptick in biosimilar antibody products approved by FDA

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The US Food and Drug Administration (FDA) began approving biosimilar products in 2015. According to FDA’s definition, a biosimilar is highly similar to, and has no clinically meaningful differences in safety, purity, and potency from, an existing FDA-approved reference product. The availability of these products can help patients by increasing the number of medication options at potentially lower costs.

 

During March 2015 to July 2019, FDA approved a total of 16 antibody therapeutics that are biosimilars of 5 reference products:

  • Trastuzumab (5 biosimilars)
  • Adalimumab (4 biosimilars)
  • Infliximab (3 biosimilars)
  • Bevacizumab (2 biosimilars)
  • Rituximab (2 biosimilars)

Notably, the rate of FDA approvals has increased in 2019. The numbers of  biosimilar antibody therapeutics approved by FDA were 0, 2, 5, and 3 for the years 2015-2018, while a total of 6 were approved in the first 7 months of 2019. The products approved in 2019 are:

Patients may soon also have access to ranibizumab and denosumab biosimilar antibody products.

  • Formycon and Bioeq IP AG recently announced that an FDA submission for FYB201, a biosimilar candidate for Lucentis®* (ranibizumab), is expected for the beginning of the fourth quarter of 2019. The submission to the European Medicines Agency (EMA) is scheduled for the first quarter of 2020. If the submissions progress as planned, marketing authorization approvals in the US and the EU are expected in 2021.
  • SB11, a proposed ranibizumab biosimilar to Lucentis is undergoing evaluation in a Phase 3 study (NCT03150589) of patients with neovascular age-related macular degeneration. Sponsored by Samsung Bioepis Co., Ltd., the study is active, but no longer recruiting patients. The estimated completion date of the study is in November 2019.
  • Sandoz recently announced the first patient was enrolled an integrated Phase 1/3 clinical study (NCT03974100) that will compare the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of GP2411 (proposed biosimilar denosumab) and Prolia® (EU-authorized) in postmenopausal women with osteoporosis. The estimated primary completion date of the study is in December 2021.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Located in the ‘Web Resources’ section of our website, the list is updated regularly and can be downloaded in Excel format. Information about antibody therapeutics that may enter regulatory review in 2019 can be found in ‘Antibodies to watch in 2019’.

FDA approves Amjevita® (adalimumab-atto) as a biosimilar to Humira®

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Antibody impressionThe US Food and Drug Administration has approved Amjevita® (adalimumab-atto) as a biosimilar to Humira® (adalimumab). In adult patients, Amjevita® is approved for moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. Amjevita® is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.
Amjevita® is the third antibody-based drug to gain approval as a biosimilar in the US this year. Inflectra® (infliximab-dyyb), a biosimilar to Remicade® (infliximab), was approved in April 2016 and Erelzi® (etanercept-szzs) , a biosimilar to Enbrel® (etanercept), was approved in August 2016.

Antibody-based biosimilar products approved in the EU or US

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Antibody impressionThe number of antibody-based biosimilar therapeutics approved in the European Union or United States is poised to grow substantially in 2016 and 2017. The originator products that target tumor necrosis factor (TNF) have been of particular interest to the biosimilar industry due to the expiration of key patents and the large global markets for the products. In 2013, the three top-selling originator anti-TNF products were infliximab (Remicade®), etanercept (Enbrel®) and adalimumab (Humira®), which combined had global sales of nearly $18 billion that year. The first biosimilar anti-TNF products approved in either the EU or US were Inflectra® and Remsima®, both of which are versions of infliximab.  Inflectra® and Remsima® were approved in the EU in September 2013 for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

While no antibody-based biosimilar products were approved in either the EU or US in 2014 or 2015, two products have been approved in each of these regions so far in 2016, and more may be approved soon. In the EU, the biosimilar etanercept BENEPALI® was approved in January 2016 for moderate to severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis, severe non-radiographic axial spondyloarthritis, and plaque psoriasis, and the biosimilar infliximab Flixabi® was approved in May 2016 for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. In the US, Inflectra® was approved in April 2016 for the treatment of moderately to moderately to severely active rheumatoid arthritis, severely active Crohn’s disease, moderately to severely active ulcerative colitis, active ankylosing spondylitis, active psoriatic arthritis, chronic severe plaque psoriasis, and the biosimilar etanercept Erelzi® was approved in August 2016 for moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, and chronic moderate to severe plaque psoriasis. A biosimilar adalimumab (ABP-501) may be approved soon, as the Food and Drug Administration’s (FDA) Arthritis Advisory Committee voted unanimously to support approval of it in July 2016. The product was recommended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, and plaque psoriasis.

Although the FDA does not release comprehensive lists of products in review, the European Medicines Agency (EMA) does provide limited information on applications for centralized marketing authorization under evaluation. As of August 3, 2016, a total of 6 applications for biosimilar adalimumab (3 applications), etanercept (1 application), and the anti-CD20 rituximab (2 applications) were under evaluation. In late August, EMA also accepted for review a marketing authorization application for a proposed biosimilar trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. Thus, there may soon be as many as 11 biosimilar antibody-based therapeutics on the market in the EU, and many of these could also gain approval in the US.