EU Biosimilar Action: New Competitors For Remicade/Herceptin, Four More Products Await CHMP OK
Two more biosimilar medicines have been approved in the EU: Sandoz’s Zessly (infliximab) and Amgen’s Kanjinti (trastuzumab). Four other biosimilars are expecting a CHMP opinion this week, including three versions of AbbVie's Humira.
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Takhzyro Among Hopefuls For EU Approval Recommendation
A handful of companies are expected to find out this week whether their products will be recommended for EU approval. The EMA's drug evaluation committee, the CHMP, is due to give its opinion on marketing authorization on two orphan drugs for use in HAE and myotonia respectively, another biosimilar trastuzumab, and a flu vaccine.
Pivotal Data Put Roche's Kadcyla In Position For Earlier Breast Cancer
KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of breast cancer.
Biosimilar Infliximab Success Paves The Way For Adalimumab In Europe
With the impending European launch of Humira biosimilar adalimumab in October, Scrip talks to some of those in the region that have experience in launching commercially successful biosimilars about uptake, discounts and payer attitudes.