Biosimilars

EMA approval for Teva’s long-acting recombinant G-CSF

Biosimilars/News | Posted 23/08/2013

The European Medicines Agency (EMA) has granted marketing authorization for a new long-acting filgrastim – Lonquex (XM22 lipegfilgrastim) – to prevent chemotherapy-induced neutropenia in cancer patients.

Assessment of efficacy and safety of biosimilars in rheumatology

Biosimilars/Research | Posted 16/08/2013

During the last decade, the availability of biological therapies has revolutionized the treatment of rheumatoid arthritis. Biologicals, unlike small-molecule chemical drugs, are extremely complex molecules, making producing biosimilars far from a simple process.

AstraZeneca pursuing biosimilars with Celltrion bid

Biosimilars/News | Posted 16/08/2013

Pharma giant AstraZeneca is rumoured to be ready to join the race for biosimilars with a bid for South Korean biotechnology company Celltrion.

Cost savings from use of biosimilars in rheumatology

Biosimilars/Research | Posted 09/08/2013

The treatment of rheumatoid arthritis provides a clear argument in favour of developing biosimilars and the need to collect sufficient pharmacological data to validate their bioequivalence and interchangeability.

Teva and Lonza end biosimilars agreement

Biosimilars/News | Posted 09/08/2013

Despite Switzerland-based API producer Lonza denying reports back in April 2013 that it was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva) that is just what has happened.

EMA reviewing biosimilar insulin application

Biosimilars/News | Posted 02/08/2013

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released on 4 July 2013 the agency is now reviewing a new application for a biosimilar insulin product.

Biosimilar G-CSF prescribed more than originator

Biosimilars/News | Posted 02/08/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 22 July 2013 that its biosimilar granulocyte colony-stimulating factor (G-CSF) Zarzio (filgrastim) has overtaken the originator product in terms of prescriptions.

Regulation of similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 02/08/2013

Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products [1, 2].

EMA approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 05/07/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing authorization for the first monoclonal antibody biosimilar, marketed under two trade names, Remsima (Celltrion) and Inflectra (Hospira) with different marketing authorization, different EPAR, and different packaging.

Biosimilars applications under review by EMA – 2013 Q2

Biosimilars/General | Posted 05/07/2013

Last update: 15 October 2013

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the 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.