Division of Novartis AG
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A total of 16 biosimilar products were approved in 2017, including the first competitors to five biologic blockbusters. Coincidentally, 16 other biosimilars are also under evaluation by the European Medicines Agency’s main scientific committee, the CHMP, including six versions of Amgen’s Neulasta (pegfilgrastim) and five more biosimilars of AbbVie’s Humira.
In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.
Ability to design a statistical analysis plan is hampered by lack of control over, and even knowledge of, changes in the reference product's quality attributes over time, biosimilar industry says in comments on US FDA's draft guidance on statistical approaches to analytical similarity; companies seek more flexibility on statistical testing methods and on source and number of products lots for analytical comparisons.
A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.
- Generic Drugs
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Greg Nulty, CFO, VP & CFO, NA
Peter Goldschmidt, Pres.
Patrick Genestin, VP, Bus. Dev. & Licensing
Carlos Sattler, MD, VP, Clin. Dev. & Medical Affairs
Scott Smith, VP, Commercial Operations, US
Anthony Maffia, III, VP, Regulatory Affairs
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