In a continuation from Part 3 of this panel discussion, 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 the pace of biosimilars market entry has been different…
As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its application after reportedly addressing the issues identified by FDA. Yesterday, the FDA approved Sandoz’s application. The biosimilar, named ZIEXTENZO, is an injectable formulation of pegfilgrastim-bmez, with…
Earlier this week, during its 3Q 2019 earnings call, Pfizer announced the U.S. launch dates for three of its biosimilar products: ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN, which received approval in June, will launch December 31, 2019. We previously posted that on September 20, 2019, Genentech and Pfizer settled…
In 2017, the Health Department of Brazil’s Federal District ordered that patients currently prescribed Remicade (infliximab) be switched over to the biosimilar, Remsima. Earlier this month, researchers in Brazil published a one-year follow-up study of patients who underwent the switch. They reported that, “[l]ike previous European studies, [their] results suggest…
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…