Over the last two weeks, NeuClone and Formycon announced updates regarding their respective ustekinumab biosimilars (reference product, Stelara). On October 17, 2019, NeuClone announced that it has launched a Phase I clinical trial of its ustekinumab product, NeuLara. NeuClone stated that the Phase I clinical trial is a “single-dose, double-blind, randomised,…
Last week, the World Health Organization (WHO) announced that it signed a memorandum of understanding with the International Generic and Biosimilar Medicines Association (IGBA) to promote access to generics and biosimilars. According to the WHO press release, the memorandum underscores “the importance of generic and biosimilar medicines to increasing access…
This month, the Star Ratings for Biosimilars Act was introduced in the House. H.R. 4629 is a bipartisan bill that requires the U.S. Department of Health and Human Services (HHS) to evaluate Medicare Advantage (MA) plans based on whether biosimilars are available to enrollees, and adds “a new set of…
In a continuation from Part 1 and Part 2, Goodwin and Bristows continue their discussion with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why it’s been so different in those two markets, and what…
On October 8, the Institute for Clinical and Economic Review (ICER) published their first report of Unsupported Price Increases (UPIs), aimed at identifying drug price increases that ICER determines are not justified by new clinical evidence or other factors. ICER selected the top 100 drugs to review based on those whose…
On October 15, 2019, Genentech filed reply briefs in support of its Federal Circuit appeals from the PTAB’s final written decisions of unpatentability of the challenged claims of U.S. Patent Nos. 7,846,441 and 7,892,549, which are directed to methods of treating HER2+ cancer with trastuzumab (Cases Nos. 19-1263, 19-1265, 19-1267…
On October 7, 2019, Mylan Pharmaceuticals filed 2 Petitions for Inter Partes Review (IPR2019-01657 and IPR2019-01658) of U.S. Patent RE47,614, which is assigned to Sanofi-Aventis. The ’614 patent claims a configuration for securely holding a cartridge within a drug delivery device, which can be used to deliver insulin. The petitions…
Indian pharmaceutical company Strides Pharma Science Ltd. will invest up to $40 million into Stelis Biopharma Pvt. Ltd. in order to regain a controlling stake, multiple sources are reporting. So far, Strides has invested $35 million for a 43% ownership stake in Stelis. According to the articles, Strides plans to use its controlling…
Following on Part 1 of this series, Goodwin and Bristows continue their discussion with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why it’s been so different in those two markets, and what the future…
On September 25, 2019, Tanvex BioPharma announced that it received a complete response letter from the U.S. FDA indicating that Tanvex’s abbreviated Biologics License Application (aBLA) for its proposed filgrastim biosimilar, TX01, was not in condition for approval. Tanvex reported that FDA “did not request additional clinical data or express…