Biosimilars/General

Biosimilars applications under review by EMA – January 2019

Biosimilars/General | Posted 25/01/2019

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Boehringer Ingelheim and Sandoz abandon biosimilars

Biosimilars/General | Posted 07/12/2018

Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.

Merck gains US infliximab contract but drops insulin glargine biosimilar

Biosimilars/General | Posted 02/11/2018

US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.

Originator biologicals and biosimilars under attack in UK and Japan

Biosimilars/General | Posted 26/10/2018

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

Comments on FDA’s public meeting on biosimilars

Biosimilars/General | Posted 12/10/2018

Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.

Biocon’s biosimilars plant gains clearance from FDA

Biosimilars/General | Posted 05/10/2018

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.

Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra

Biosimilars/General | Posted 28/09/2018

Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).

Improving understanding of biotherapeutics and biosimilars

Biosimilars/General | Posted 21/09/2018

Additional information on biosimilars and biotherapeutics have been published in Europe.

Extension of indications and manufacturing approval for biologicals in the US

Biosimilars/General | Posted 14/09/2018

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.

FDA guidance sought on false and misleading information on biosimilars

Biosimilars/General | Posted 07/09/2018

Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.