Tagged as: biosimilar

Boehringer Ingelheim Announces Positive Phase III Results for Its Adalimumab Biosimilar

On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis.  According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…

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STADA Acquires Majority Stake in Epoetin Biosimilar Licensor BIOCEUTICALS

On August 6, 2018, STADA Arzneimittel AG (“STADA”) announced that it had acquired a majority stake in BIOCEUTICALS Arzneimittel AG (“BIOCEUTICALS”).  According to the press release, STADA is acquiring an additional 35.48 percent of the shares in BIOCEUTICALS  from its co-shareholders to bring its total stake to 51.34 percent.  BIOCEUTICALS…

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Biosimilar Litigation Updates

Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…

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Big Molecule Watch Editor Nick Mitrokostas to Speak at ACI Annual Biosimilars Summit

On June 25-June 27th, at the Intercontinental New York Times Square, industry leaders from both innovator and biosimilar companies will convene at ACI’s 9th Annual Summit on Biosimilars to discuss the future of biosimilars and formulate solutions to the complex regulatory and patent challenges ahead. Goodwin is a proud sponsor…

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Samsung Bioepis Reports One-Year Follow-Up Results for Trastuzumab Biosimilar

According to an announcement by Samsung Bioepis, an additional one-year follow-up study on SB3, a biosimilar candidate referencing Herceptin® (trastuzumab), showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to trastuzumab in patients with HER2-positive early or locally advanced breast cancer. The data…

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FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

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LG Chem Tests LBEC0101, a Biosimilar to Enbrel (etanercept), in Rheumatoid Arthritis

The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published.  The study evaluated the similarities between LBEC0101 and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid…

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