Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Fingernail psoriasis affects half of all psoriasis patients and HUMIRA is now the first-and-only biologic treatment with data on fingernail…
As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11 professors “teach and write on patent law and policy, and the economics of the biopharmaceutical industry,” and “are concerned with the…
Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly complete the development of” the product and “cooperate for its approval, production and marketing in China”. The article states…
FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug approved by the FDA for treatment of PPMS, which the CDC estimates affects 15% of patients with multiple sclerosis….
Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. As we reported last week, Sanofi and Regeneron have filed…
As we previously reported, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade association representing various members of the biotechnology industry, filed an amicus brief in support of Amgen. The brief argues that…
Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging U.S. Patent 7,371,379. According to the Petitions, the patents are drawn to methods for treating cancer by administering trastuzumab and a chemotherapeutic agent. Trastuzumab is sold…
As we posted here, here, and here, various amicus briefs have been submitted in Sandoz v. Amgen. Last week, Janssen Biotech, Inc. submitted an amicus brief in support of Amgen. Janssen’s brief emphasizes two points. First, Janssen asserts that the express statutory purpose of the 180-day notice of commercial marketing is to…
This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S. Patent & Trademark Office. The ’487 patent is directed to an “isolated human antibody that competes with…
Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. AMGEVITA is Amgen’s first biosimilar approved by the EC. Amgen states in its press release that “AMGEVITA was approved in the United States (U.S.) by…