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No Slowdown for Antibody Product Approvals in 2017

Antibody related products[1] have been a staple in the biopharmaceutical landscape for over 10 years. In preparing a chapter for a soon to be published road map for developing therapeutic monoclonal antibody products, the reality became clear that antibody related products are the cornerstone of the biopharmaceutical market. Representing over a third (35%) of all approved and currently marketed recombinant products (73 of 208), antibody products generated just over $89B of the $154B in sales of biopharmaceuticals for 2015.[2]

Since recombinant products entered the market in 1982, 88 antibody related products have been approved over the last 34 years.[3] If we take a closer look at the number of antibody related products approved every year, since the approval the first therapeutic monoclonal antibody Orthoclone OKT3 in 1986, the number of antibody products have steadily increased over the last few years with 2016 recording an unprecedented approval of 11 antibody products by the FDA and the EMA (see Figure 1 below). Of the 2016 approved products, seven are full length monoclonal antibodies: Anthim, Cinqair/Cinqaero, Lartruvo, Taltz, Tecentriq, Zinbryta and Zinplava, two are biosimilar antibodies: Amjevita and Flixabi, while the remaining two products are biosimilar Fc-fusion proteins: Erelzi and Benepali.

Surveying the overall recombinant biopharmaceutical pipeline, it is clear from our bioTRAK® database that antibody products continue to dominate the development pipeline. Of the over 400 products in late stage development (Phase 2 through BLA/MAA/NDA application), approximately 70% are antibody related products. The majority of these antibody products (90%) are produced in mammalian systems.

As we enter 2017, there is significant potential for another strong year for antibody product approvals. There are currently 27 products awaiting FDA or EMA approval, 14 of which are mammalian-based antibody products. Eight of the products are full length monoclonal antibodies: an anti-IL-1a Ab, avelumab, brodalumab, dupilumab, guselkumab, ocrelizumab, sarilumab and sirukumab, and five are biosimilars including an adalimumab biosimilar, a bevacizumab biosimilar, a rituximab biosimilar, and two trastuzumab biosimilars.

If we look even further back into the pipeline, there are nearly mammalian-based 260 antibody related products in development, with nearly a quarter in Phase 3. Although many of these products are still in active clinical trials, we expect that some of these products may possibly file for review and be approved before the end of 2017.

As the development and commercialization of antibody products continue to forge ahead with no slowdown in sight, antibodies will remain the cornerstone of the biopharmaceutical market for the foreseeable future.

 

[1] 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 or diagnostic use in humans.

[2] Sales data for biopharmaceuticals sold in 2016 have not yet been released. Please check back for a new blog revealing 2016 sales in April of 2017.

[3] Fifteen antibody products have been since withdrawn from the market.

 

Blog article by: Dawn M. Ecker