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General

Biosimilars applications under review by EMA – January 2018

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.

Roche sues Pfizer over Herceptin biosimilar

Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug Herceptin (trastuzumab) in an attempt to block competition from Pfizer’s trastuzumab biosimilar.

EC publishes biosimilar Q&A document for patients in 23 languages

On 29 November 2017, the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.

Biosimilars of palivizumab

Palivizumab is a humanized monoclonal antibody. It targets the fusion protein of respiratory syncytial virus (RSV) inhibiting its entry into the cell and thereby preventing infection. Palivizumab is therefore used in the prevention of RSV infections.

UK launches campaign to promote research on biosimilars

A new campaign launched by the UK’s National Institute for Health Research (NIHR) aims to unlock the potential benefits of biosimilars in the National Health Service (NHS) through clinical trials.

Hospira to pay Amgen US$70 million for epoetin alfa patent infringement

US-based injectables specialist Hospira has been ordered to pay Biotech giant Amgen US$70 million in damages regarding a patent on Amgen’s anaemia blockbuster Epogen (epoetin alfa).

FDA launches educational campaign for biosimilars

In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) announced on 23 October 2017 the launch of its education campaign for biosimilars.

NHS England to increase biosimilar usage

On 12 September 2017, National Health Service (NHS) England released a ‘Commissioning framework for biological medicines (including biosimilar medicines)’. In this document, they make a series of recommendations with the aim of increasing both biological and biosimilar uptake. As a result of increased competition between biologicals, creating better value biological medicines and biosimilars, NHS England believes that it can make savings of GBP 200 − GBP 300 million a year by 2020/21 by increasing uptake of these better value biologicals.

FDA updates Purple Book for biologicals and biosimilars

On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.

Biosimilars of omalizumab

Last update: 3 November 2017

Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes [1]. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells. The originator product Novartis’s Xolair (omalizumab) is indicated for the treatment of moderate to severe persistent asthma and chronic idiopathic urticaria despite antihistamine treatment.