Biologics and Biosimilars Bits and Bytes – December 10, 2015

Amgen files for first European Approval of a Biosimilar to Humira®

On December 4, 2015, Amgen Inc. (Amgen) announced the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for ABP 501, a biosimilar version of AbbVie Inc.’s (AbbVie) Humira® (adalimumab). According to Amgen, its MAA submission included analytical, clinical and pharmacokinetic data. Amgen conducted Phase 3 comparative efficacy and safety studies in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Amgen indicated that its Phase 3 studies met their primary endpoints showing clinical equivalence to Humira®. The safety and immunogenicity of ABP 501 was also comparable to Humira®. Additionally, data to support the transition of Humira® patients to ABP 501 was also included in the filing.

This MAA filing follows Amgen’s November 25, 2015 filing of a 351(k) application with the U.S. Food and Drug Administration (FDA) for ABP 501.

Coherus Files Two New IPR Petitions against AbbVie’s Patents Covering Humira®

On December 7, 2015, Coherus Biosciences Inc. (Coherus) filed two new IPR petitions, IPR2016-00188 and IPR2016-00189, against AbbVie’s U.S. Patent Nos. 9,017,680 and 9,073,987 covering Humira®. These filings come almost a month after the November 9th filing by Coherus of IPR petition, IPR2016-00172, against another AbbVie patent covering Humira®, U.S. Patent No. 8,889,135. Coherus’ three IPR petitions can be found here: 1. IPR201600188 2. IPR201600189 3. IPR201600172. This brings the total number of IPR petitions filed against AbbVie patents covering Humira® to five. Earlier this year, on June 26, 2015 Amgen filed IPR petitions, IPR2015-01514 and IPR2015-01517 against two other AbbVie patents, U.S. Patent Nos. 8,916,157 and 8,916,158.

Infliximab Biosimilar Approved in Korea

On December 4, 2015, Samsung Bioepis Co., Ltd., (Samsung Bioepis) announced that Korea’s Ministry of Food and Drug Safety (MFDS) approved Renflexis®, a biosimilar version of Remicade® (infliximab), also known as SB2. Renflexis® was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This is the second biosimilar approved in Korea for Samsung Bioepsis, a joint venture between Biogen and Samsung Biologics. The first approval was in September 2015 for Brenzys®, a biosimilar version of Enbrel® (etanercept), also known as SB4.

In February 2013, Samsung Bioepis and Merck & Co. (Merck) announced a development and commercialization agreement under which Merck would commercialize multiple pre-specified and undisclosed biosimilar products in certain partnered territories. Under terms of the agreement, Samsung Bioepis was responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Merck was responsible for commercialization. As a result, Merck will commercialize Renflexis® in South Korea and plans to launch in the first half of 2016.

This post was written by Lisa Mueller.


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