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© 2020 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2020 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
August 13, 2020
The company has launched its biosimilar rituximab, Ritucad, for the Indian market.
The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).
The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.
August 05, 2020
The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.
July 01, 2020
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
April 08, 2020
Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.
April 02, 2020
FDA is encouraging alternative insulins and challenging anticompetitive practices.
February 21, 2020
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.
February 06, 2020
The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.