Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and 26 of U.S. Patent No. 10,130,681, and IPR2022-01226 challenging claims 1-9, 34-39, 41-43, and 45 of U.S. Patent No….
Goodwin is actively seeking Science Advisors to join its Intellectual Property (IP) Litigation group. IP litigation requires both an understanding of the law and a firm handle on the technical aspects of the patents at issue, especially when the patents cover complex technologies including those in the pharmaceutical space. “Science…
On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.” The recalled product is not the branded SEMGLEE® pen, but rather the unbranded…
In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®. On July 4, 2022, Xbrane announced that based on comments and recommendations in a General Advice letter received from FDA, “Xbrane plans to resubmit the [ranibizumab] BLA during 2022,” and that…
Amgen recently released a preview of its 2022 Trends in Biosimilars Report, which includes an analysis of the trends in US biosimilar launches and approvals; a timeline of biosimilar approvals and launch dates; trends in pricing, uptake, and total drug spend; and considerations for the future of biosimilars. According to…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products. On June 23, 2022, CHMP recommended the grant of a marketing authorization for RANIVISIO (ranibizumab) to Midas Pharma GmbH. RANIVISIO references LUCENTIS® and, if approved, would be used to…
On June 24, 2022, Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab)—a monoclonal antibody that targets and binds to PD-1 molecules resulting in the death of cancer cells—in combination with…
Formycon recently announced its sales and earnings figures for the first quarter of 2022. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), which was in line with expectations. According to the press release, the reported revenues were mainly a result…
Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab). The indications covered in the application include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis. According to the press release, Sandoz has conducted a…
The ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics will be held on June 28 – 29, to contemplate the details of the rapidly changing landscape for biosimilars and innovator biologics. Goodwin is a proud sponsor of the conference and, Goodwin partner and Big Molecule Watch editor, Huiya Wu is a…