Dosage Forms

Articles

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

Cadila Pharmaceuticals Launches Biosimilar Rituximab 

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Henlius and Accord Healthcare Receive European Approval for Biosimilar Trastuzumab

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

CHMP Gives Positive Opinion on Centus Biotherapeutics’ Bevacizumab Biosimilar

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Analytical Assays Determine Biosimilar Product Quality

George I’ons is head of Product Strategy and Insights, Owen Mumford Pharmaceutical Services.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.


The Design Driver for Biosimilar Adoption

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Biosimilars Poised for Gains in US Market

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. 

FDA Smooths Transition of Biologic Approvals

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

FDA and FTC Collaborate on Competitive Biologics Market

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

Biosimilars and Biobetters