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June 23, 2017
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
June 20, 2017
The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.
June 12, 2017
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
May 15, 2017
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
May 05, 2017
The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.
April 24, 2017
Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.
Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and etanercept in Europe, for the same indications as the respective reference medicines.
February 15, 2017
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.