Tagged as: biosimilar

AbbVie Grants Momenta Global Patent Licenses for Biosimilar of HUMIRA (Adalimumab)

Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab).  According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States…

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Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case

As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a…

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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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