On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada.
Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic,...more
On June 8, 2022, a bipartisan group of U.S. Senators sent a letter to Kathi Vidal, Director of the U.S. Patent & Trademark Office, requesting that the PTO take action on patent thickets. According to the Senators, “large...more
On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab). According to the press release,...more
It has been a busy last few weeks for biosimilar developers, with multiple deals announced.
On March 29, 2022, it was announced that Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) have agreed to merge their development...more
Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes...more
Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA. According to the press release, the biosimilar trastuzumab was...more
Today, Coherus BioSciences, Inc. announced that the FDA approved YUSIMRY (adalimumab-aqvh), a biosimilar of AbbVie’s HUMIRA product. YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis,...more