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EMA approves adalimumab and pegfilgrastim biosimilars Biosimilars/News | Posted 31/08/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it had recommended granting marketing authorization for the adalimumab bio...

Alternative mAb purification strategies: a tool to increase global access to biotherapeutics? Biosimilars/Research | Posted 31/08/2018

The monoclonal antibodies’ (mAbs) market is dominant among therapeutic biologicals. Between 2013 and 2017, it has witnessed the approval of 11 biosimilars and 33 new molecules by the regulatory aut...

AbbVie signs another licensing deal for adalimumab biosimilar Pharma News | Posted 31/08/2018

US-based pharma giant AbbVie has signed yet another licensing deal for a biosimilar version of its blockbuster arthritis drug Humira (adalimumab).

FDA issues final guidance on ANDA/PAS amendments Guidelines | Posted 31/08/2018

The US Food and Drug Administration (FDA) has issued final guidance outlining the agency’s review goals for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (P...

Positive switching data for infliximab and etanercept biosimilars Biosimilars/Research | Posted 31/08/2018

Sandoz, the generics division of Novartis, announced on 15 June 2018 results of new phase III, long-term and switching data for its infliximab biosimilar Zessly (PF‑06438179) and its etanercept bio...

Ulcerative colitis and diabetes generics launched in US Generics/News | Posted 31/08/2018

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 9 July 2018 that it had launched generic budesonide extended-release tablets (9 mg) in the US. Then on 25 July 2018 In...

EU reinforces collaborations with US and Japan Policies & Legislation | Posted 31/08/2018

The European Union (EU) is reinforcing its collaborations with both the US and Japan.

Lot selection and handling for biosimilarity Reports | Posted 31/08/2018

In his presentation on Expectations and Approaches for Demonstrating Analytical Similarity, Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) discussed lot sel...