Tagged as: Biosimilars News

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

On November 6th, Goodwin’s Elaine Blais 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 developments affecting validity…

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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…

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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),…

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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…

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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…

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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…

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BREAKING NEWS: Jury’s $70M Award Against Hospira for Infringing Amgen's Epoetin Patent Survives Post-Trial Motions

As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar of Amgen’s Epogen® (epoetin alfa) was not protected activity under the § 271(e)(1) safe harbor and infringed Amgen’s ’298 patent, and…

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Bio-Thera Solutions Provides Regulatory and Clinical Development Updates for Proposed Biosimilars

Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar.  Bio-Thera states that the BAT1406 BLA contains clinical data from a pharmacokinetic/pharmacodynamic (PK/PD) trial and a Phase III confirmatory safety and efficacy study in…

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