On July 24, 2014, Sandoz Inc. (Sandoz) became the first company to publicly announce acceptance by the U.S. Food and Drug Administration (FDA) of a biologics license application under the biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). Specifically, Sandoz is seeking licensure for a version of the protein filgrastim. Filgrastim is a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor used to decrease the incidence of infection caused by febrile neutropenia in patients suffering from non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs. The reference product is Neupogen®, sold by Amgen.

Sandoz has significant experience with filgrastim. Sandoz currently markets a biosimilar version of filgrastim in over 40 countries under the name of Zarzio®. In fact, Zarzio® is the number one filgrastim biosimilar in the world.

Because Sandoz’ application has been accepted, Sandoz and Amgen are required to participate in a series of exchanges beginning as early as 20 days after receipt of FDA’s notification of acceptance to determine which patents, if any, to litigate. It will be interesting to see if any litigation ensues as several key patents covering Neupogen® have expired (namely, U.S. Patent Nos. 4,810,643, 4,999,291, 5,580,755 and 5,582,823).

If Sandoz receives approval for Zarzio®, it will not be the first filgrastim product (other than Neuopogen®) that has received approval by the FDA (although Zarzio® may be the first biosimilar approved under the BPCIA). In August 2012, Teva Pharmaceuticals Industries Ltd. received approval from the FDA of its full biologics application (a Section 351(a) application) for tbo-filgrastim.

Will Sandoz be the first company to receive approval for a biosimilar in the U.S.? Perhaps. However, it appears that Sandoz may have some competition. On March 31, 2014, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively, Celltrion), filed a complaint for declaratory judgment against Janssen Biotech, Inc. (Janssen), alleging invalidity and unenforceability of three Jansen patents (U.S. Patent Nos. 5,919,452, 6,284,471 and 7,223,396) that are alleged to cover Janssen’s antibody drug infliximab (Remicade®). Remicade® is approved for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

In the complaint, Celltrion states that it has developed a biosimilar version of Remicade®, called Remsima®, and it intends to apply for marketing approval of Remsima® in the first half of 2014. Specifically, on pages 2-3 of the complaint, Celltrion states, “[C]elltrion expects the U.S. Food & Drug Administration (FDA) to approve Remsima® by early 2015 (assuming the approval process is not hindered by interference from Janssen or its affiliates). Remsima® will become the first biosimilar of an antibody drug every approved in the United States.”

So, the race for approval by the FDA of the first biosimilar appears to have started. Who will reach the finish line first? Sandoz? Celltrion? Or, will it be another company that has quietly filed for approval? Hopefully, we will have some answers by early to middle 2015. Stay tuned!