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2015 – A Record Year for Antibody Product Approvals, But Not For Biopharmaceuticals Overall

Recombinant biopharmaceutical products have been a growing sector in the pharmaceutical landscape for over 10 years and antibody related products[i] are undoubtedly the cornerstone of the biopharmaceutical market. Based on a query of BPTC’s bioTRAK® database at the close of 2015, there were 194 recombinant therapeutic biopharmaceuticals approved on the US/EU market. Antibody related products represented nearly a third (1/3) of these products (57 of 194) and generated over half ($85B) of the $152B in sales of biopharmaceuticals for 2014.[ii]

Since recombinant products entered the market in 1982, 215 therapeutic products consisting of 69 antibody related therapeutics and 146 non-antibody therapeutics have been approved over the last 33 years.[iii] Although the FDA’s total approvals reached its highest levels since 1996 with 45 new active ingredient approvals and the EMA followed close behind with 39 new active substance approvals, 2015’s approvals for biopharmaceuticals were less than 2014 (see Figure 1 below, 13 vs. 21).

If we take a closer look of the total number of recombinant products approved every year since the approval of Humulin in 1982, in 2015 only three recombinant products were approved compared to 14 in 2014. The three 2015 approved products were all recombinant blood proteins – Ixinity, Vonvendi, and Adynovate.

With the approval of the first therapeutic monoclonal antibody Orthoclone OKT3 in 1986, 2015 saw a record number of antibody related approvals (10), surpassing 2014’s record of seven antibody product approvals. Of the 2015 approved products, eight are full length monoclonal antibodies: Cosentyx, Darzalex, Empliciti, Nucala, Portrazza, Praluent, Repatha, and Unituxin. The remaining two products consist of an Fc-fusion protein, Strensiq and an antibody fragment, Praxbind.

As we begin 2016, it is possible that the coming year’s approvals may surpass previous records for biopharmaceutical approvals in 2014 as well as antibody product approvals 2015. BPTC’s bioTRAK® database currently lists 22 products under FDA or EMA review, which could be approved in 2016 (see Table 1 below).

If we look even further back into the pipeline, it is clear from our bioTRAK® database that the interest in the development of biopharmaceuticals is strong, with over 450 recombinant products in Phase 2 or Phase 3 development. Over 70% of these clinical products are antibody related products. Although many of these products are still in active clinical trials, it is possible that some of these products may possibly file for review and be approved before the end of 2016.

As full pipelines and strong interest in biopharmaceuticals continues into the latter part of this decade, it is very likely that biopharmaceutical approvals will continue increasing their impact on the pharmaceutical landscape, with antibodies remaining the cornerstone of the biopharmaceutical market for the foreseeable future.

















Blog article by: Dawn M. Ecker





[i] We consider antibody products to include full length monoclonal antibodies, antibody fragments (Fab fragments), Fc-fusion proteins, antibody-drug conjugates, and other conjugated antibody products for therapeutic use in humans.

[ii] Sales data for biopharmaceuticals sold in 2015 have not yet been released. Please check back for a new blog revealing 2015 sales.

[iii] Eleven therapeutic antibody products and 10 non-antibody recombinant therapeutics have been since withdrawn from the market.