An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on Tuesday. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s GP2015 biosimilar of Amgen’s Enbrel (etanercept) today. Our previous coverage noted that the FDA made a preliminary determination that ABP501 is “highly similar”…
Sandoz has announced plans to expand its biosimilars offerings within the next five years, including a total of 11 filings by the end of 2017, and 5 launches by 2020. Sandoz says that its next five launches will be biosimilars to Enbrel® (etanercept), Humira® (adalimumab), Neulasta ® (pegfilgrastim), Remicade® (infliximab)…
According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its 2013 value. Six biosimilars have been approved in South Korea since 2012, and dozens of other biosimilars are currently in the development…
At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from Biogen, a partner in the Samsung Bioepis joint venture with Samsung BioLogics, Phase III studies for those anti-TNF-α biosimilars have demonstrated that…
We previously reported on Sandoz’s aBLA for a biosimilar of Amgen’s ENBREL (etanercept) and the related BPCIA litigation. The FDA’s Arthritis Advisory Committee announced this morning that it will hold a public advisory committee meeting on July 13, 2016 to discuss Sandoz’s etanercept biosimilar. According to the announcement, anyone wishing to…
Amgen, Hoffmann-La Roche and Immunex have filed a complaint in the District of New Jersey against Sandoz alleging patent infringement of the plaintiffs’ etanercept (ENBREL) patents under the BPCIA provisions of 35 U.S.C. § 271. The plaintiffs are also seeking declaratory judgment of patent infringement on the grounds that Sandoz…
The National Institute for Health and Care Excellence (“NICE”) released guidance today establishing a preference for lower-cost biosimilars for the treatment of rheumatoid arthritis. NICE is an agency that provides cost-effectiveness and other guidance to the National Health Service (“NHS”) and other British public health services. The guidance document released today provides…
Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe….
On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. This is the second biosimilar antibody drug that…