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Biotechnology Biologics European Union

Goodwin

European Biosimilar Updates - Alvotech/Advanz’s MYNZEPLI Approval and Bio-Thera/STADA Tocilizumab Alliance

Goodwin on

On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Goodwin

Global Biosimilar Update

Goodwin on

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Hogan Lovells

EMA released reflexion paper clarifying information related to the selection of starting materials

Hogan Lovells on

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides...more

Jones Day

Clarifying or Conforming? The EPO Bows to the European Commission

Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Foley & Lardner LLP

EPO Stays Proceedings Over Patentability Of Plants And Animals

Foley & Lardner LLP on

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

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