Tagged as: Biosimilars News

Coherus Plans to Launch UDENYCA (pegfilgrastim-cbqv) in U.S. in January at 33% Discount

On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv) biosimilar product.  President, CEO and Chairman Denny Lefler told financial analysts on the call that Udenyca™ will be available for…

Read More

Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti to host a Biosimilars Market Update Webinar

On November 6th, Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal…

Read More

Big Molecule Watch Editor Nick Mitrokostas to Speak at Biosimilars in the Antitrust Spotlight: Patent Litigation and Settlement Webinar

Tomorrow, October 4th, Goodwin’s Nick Mitrokostas will participate as a panelist on the Biosimilars in the Antitrust Spotlight: Patent Litigation and Settlement webinar, discussing the likely shape of settlements in patent litigation between innovator biologic companies and biosimilar aspirants, the future of non-cash forms of compensation and whether “at-risk” entry is…

Read More

European Biosimilar Approval Updates: Adalimumab, Pegfilgrastim

In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the  European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines:  (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim),…

Read More

Xbrane Shifts Strategic Focus to Biosimilars

Today, September 10, 2018, Xbrane Biopharma announced that it has decided to shift its strategic focus of capital and resources toward biosimilars and away from its pipeline of generic long-acting injectables.  In addition to moving forward with its pivotal clinical trial for Xlucane, its proposed biosimilar of Lucentis® (ranibizumab), Xbrane…

Read More

New BPCIA Complaint: Genentech Sues Samsung Bioepis Regarding Proposed Trastuzumab Biosimilar (UPDATED)

Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab).  This is the fourth litigation regarding a biosimilar of Herceptin®, following…

Read More

Biosimilar and Biologic Development Updates

On Wednesday, Celltrion announced its completion of its Phase 3 clinical trial for Remsima SC, a subcutaneous version of its biosimilar Remsima® (infliximab).  According to Celltrion, “[t]he subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to…

Read More