On October 13, 2026, Formycon and Zydus announced that the FDA accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s KEYTRUDA® (pembrolizumab). This is the first publicly announced FDA acceptance of an application for a proposed KEYTRUDA® biosimilar. Formycon also submitted the regulatory dossier to…
STADA and Sino Biopharmaceutical Limited (“SBP Group”), through its subsidiary Chia Tai Tianqing Pharmaceutical Group (“CTTQ”), have entered into a partnership to manufacture, market, and sell biosimilars. CTTQ will develop, manufacture, and supply biosimilar candidates, while STADA will hold the marketing authorizations and have exclusive sales and marketing rights in…
On September 3, 2026, InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, announced a strategic partnership and exclusive license with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck’s KEYTRUDA® (pembrolizumab), in the United States. Pembrolizumab is a humanized monoclonal antibody that…
Formycon AG (“Formycon”) announced its partnership with OneSource Specialty Pharma Limited (“One Source”) on July 14, 2026. OneSource, located in Bangalore, India, will complement Formycon’s biosimilar development experience with its biologics manufacturing capabilities. OneSource has an integrated biologics platform that ranges from cell line development to commercial fill-finish and five…
On February 11, 2026, Formycon AG and Lotus Pharmaceutical announced the execution of an exclusive license agreement directed to Formycon’s pembrolizumab biosimilar candidate, FYB206. Pembrolizumab is currently approved as KEYTRUDA (Merck Sharp & Dohme LLC) and is indicated to treat a variety of tumors. FYB206 is near the end of…
On September 18 and 19, 2025, the Patent Trial and Appeals Board (“PTAB”) issued final written decisions for four inter partes review (“IPR”) challenges brought by Merck Sharp & Dohme LLC (“Merck”) against Johns Hopkins University’s (“Johns Hopkins”) pembrolizumab patents, finding that all claims were unpatentable. The dispute between Merck…
Teva Pharmaceutical Industries Ltd. (“Teva”) and Shanghai Fosun Pharmaceutical (Group) Co. (“Fosun Pharma”) recently announced a partnership to accelerate the development of Teva’s TEV-56278, a novel fusion protein that uses Teva’s ATTENUKINE™ technology to target cytokine activity to tumor cells while reducing toxic side effects. The new drug is intended…
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings. It is well known that the…
In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods for treating cancer in a patient having a tumor that exhibits a high microsatellite instability…
In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins University (“Johns Hopkins”), U.S. Patent No. 11,591,393 (the ’393 patent). The…