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Coherus BioSciences, Inc.

http://www.coherus.com/

Latest From Coherus BioSciences, Inc.

New Oncologics Overwhelmingly Approved In US Before EU

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Regional Comparisons Approvals

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

Coherus All But Checks Out Of Biosimilars With Meitheal Adalimumab Deal

Meitheal Pharmaceuticals can begin preparations for a seminal moment, the firm’s first marketed US biosimilar, as it snapped up rights to Humira rival Yusimry from Coherus BioSciences.

Deals M & A

Biosimilars: US FDA Heralds The End Of Switching Studies For Interchangeability

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Biosimilars Guidance Documents
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • InteKrin Therapeutics, Inc.
    • Coherus Intermediate Corp
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