Goodwin Procter

The U.S. FDA recently approved Genentech’s Phesgo for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab product, the first adalimumab biosimilar to Abbvie’s Humira® approved in Japan.  Commercialization of the product will be handled by Fujifilm’s partner, Mylan.   The post…
    We previously reported on an International Trade Commission hearing in a trade secret dispute brought by Allergan and Medytox against Daewoong and Evolus.  In the underlying investigation, Allergan and Medytox seek to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  A one-page public notice provides that the Administrative Law Judge’s Initial Determination found “a violation of section 337 has occurred by reason of misappropriation of trade secrets.”  The…
Today, Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen’s biosimilars of Genentech’s HERCEPTIN (trastuzumab) and AVASTIN (bevacizumab) oncology products. According to each court submission, the parties entered into a settlement agreement and mutually agreed to voluntarily dismiss all asserted claims and counterclaims with prejudice. The settlements come on the heels of two recent appellate decisions in these litigations from the U.S.…
On July 6, 2020, the U.S. FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA. HULIO is indicated for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HUMIRA, in contrast, is additionally approved for the treatment of certain patients with pediatric Crohn’s disease, hidradenitis suppurativa, and uveitis. HULIO is the sixth biosimilar of HUMIRA to obtain FDA-approval,…
Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of Genentech’s motions to enjoin sales of MVASI in the United States.  MVASI is an FDA-approved biosimilar of Genentech’s AVASTIN. As we previously reported, in July 2019, Genentech filed an emergency motion and motion for a temporary restraining order premised on the legal…
We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture.  As we reported at the time, Sandoz intended to, and did appeal the result. Today, the Federal Circuit upheld the district court’s result, although it disagreed with portions…
The U.S. District Court for the District of Delaware has denied Amgen’s motion to consolidate a recently filed action against Pfizer and its affiliate Hospira relating to Hospira’s filgrastim biosimilar with an ongoing litigation between the parties involving the same product, which is set for trial in May 2021.  As we previously reported, Amgen filed this new lawsuit alleging that Pfizer and Hospira’s filgrastim biosimilar infringes U.S. Patent No. 10,577,392, a related family member…
On June 28, 2020, Genentech filed a complaint against Samsung Bioepis (Bioepis) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Bioepis’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). As relief, Genentech’s complaint requests a court declaration that the commercial marketing of Bioepis’s biosimilar product would infringe the asserted patents, as well as a preliminary injunction enjoining such allegedly infringing activity pending a final…
Researchers from the University of Arizona Cancer Center recently presented results of a simulation designed to model the cost savings from converting patients from pegfilgrastim to biosimilar pegfilgrastim-cbqv.  The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 29-31, 2020. The researchers conducted simulation modeling of cost savings from conversion of pegfilgrastim to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced febrile neutropenia.  The researcher team performed a number of…
Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved HLX14, a denosumab biosimilar.  Denosumab is a recombinant humanized anti-RANKL monoclonal antibody for injection that is approved for the treatment of postmenopausal women with osteoporosis with a high risk of fractures. South-Korea-based Daewon Pharmaceutical (Daewon) recently launched their teriparatide biosimilar TERROSA, to be marketed by Richter-Helm Biotec.  Teriparatide is a recombinant form of parathyroid hormone (PTH) that is indicated for…