FDA had already approved 26 new drugs by the end of August 2011 compared to only 21 approved in 2010. Of note were six cancer drugs and two ground-breaking drugs for hepatitis C. The current year looks likely set a record for recent years for new drug approvals, which may total 35–40 by the end of 2011. After a slow start in the first two months with three new drug approvals and nine rejections in January and February 2011, FDA approved four new drugs, two of which were monoclonal antibodies, in March and five in April. Of the 11 new drugs approved in the first four months, only three biologicals were approved.
- Home
-
Generics
News
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Research
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
-
Biosimilars
News
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- FDA approves interchangeable adalimumab biosimilar Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Research
- Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- MORE EDITORIAL SECTIONS
- Search
Comments (0)
Post your comment