Revance Therapeutics, Mylan, and Formycon have announced updates to their biosimilar plans. In the Q1 2020 Earnings Conference Call on May 7, 2020, Revance updated investors on the biosimilar to BOTOX® program in potential partnership with Mylan. Revance informed investors that Mylan had requested additional information from Revance, and would…
We previously covered the Patent Trial and Appeal Board’s (the “Board”) institution of inter partes reviews filed by Mylan challenging the validity of various Sanofi patents relating to devices for administering insulin glargine: IPR2018-01675, IPR2018-01676 (Patent 8,603,044 B2); IPR2018-01678, IPR2018-01679, IPR2019-00122 (Patent 8,992,486); IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2); and IPR2018-01684 (Patent…
As we previously reported, Revance Therapeutics and Mylan are collaborating in developing a biosimilar of Allergan’s BOTOX (onabotulinumtoxinA), and Mylan has an upcoming opportunity to opt in or out of the collaboration. Last week, Revance’s President and CEO, Mark Foley, announced on the company’s quarterly earnings call that “Mylan has…
Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with a user fee goal date of December 27, 2020. Mylan is the fourth biosimilar developer to report the filing of…
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). In recent weeks, several biosimilar developers have…
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order: 1) Launch of First and Second U.S. Trastuzumab Biosimilars: In July 2019, Amgen and Allergan announced the U.S. launch of KANJINTI (trastuzumab-anns),…
On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997 in favor of Mylan, thereby resolving all pending disputes between the parties in Amgen v. Mylan, Civil Action No. 17-cv-1235, the BPCIA…
Below are highlights of biosimilar development news from the past couple of weeks: On August 5, Revance Therapeutics indicated on its quarterly earnings call that it has continued to have discussions with its collaborator Mylan about their proposed biosimilar of BOTOX (onabotulinumtoxinA) since their initial advisory meeting with the FDA…
Mylan N.V. and Pfizer Inc. recently announced that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine to form a new company. According to the press release, each Mylan share would be converted into one share of the new company. Pfizer shareholders will own 57% of the combined new company,…
As we previously reported, last week the U.S. District Court for the District of Delaware denied Genentech’s motion for a preliminary injunction against Amgen in the BPCIA litigation concerning Amgen’s Kanjinti (trastuzumab-anns). A redacted version of the court’s opinion has now been posted to the public docket. As set forth…