Biosimilars/News

Biosimilar user fees proposal under review

Biosimilars/News | Posted 21/10/2011

Proposals over biosimilar user fees appear to have been ratified by stakeholders and a proposal is now under review by the US Department of Health and Human Services.

Rituximab biosimilar successfully produced in plants

Biosimilars/News | Posted 21/10/2011

iBio, a leader in the plant-made pharmaceutical field, announced on 5 October 2011 that it had successfully expanded the use of its technology to biosimilar monoclonal antibodies (mAbs) by producing rituximab in non-transgenic green plants.

Cheap biosimilars to come from India and China

Biosimilars/News | Posted 21/10/2011

On 19-20 September 2011, the United Nations (UN) held a High-Level Meeting to develop a global strategy to fight non-communicable diseases, ‘principally cardiovascular diseases, cancers, chronic respiratory diseases and diabetes.’ It is only the second global health issue that the UN General Assembly has deemed urgent enough to call a meeting to discuss. Such diseases cause approximately two-thirds of all deaths.

A snapshot of interesting new approvals by FDA

Biosimilars/News | Posted 14/10/2011

New approvals by FDA look set reach record levels in 2011. Some noteworthy drugs already approved in 2011 are discussed below.

EMA plans to revise biosimilar guidelines

Biosimilars/News | Posted 07/10/2011

EMA announced on 3 October 2011 that it has published a concept paper asking for comments on topics to be included in a potential revision of the agency’s 2006 biosimilar guideline, which covers non-clinical and clinical development of biosimilars. The paper will be released for a 3-month consultation period.

Biosimilar user fee levels and performance goals for the FDA

Biosimilars/News | Posted 07/10/2011

FDA and representatives from the drug industry negotiating a user fee for biosimilars have tentatively set performance goals and biosimilar user fee levels, creating a separate review programme for biosimilars.

Boehringer Ingelheim joins other Big Pharma going into biosimilars

Biosimilars/News | Posted 30/09/2011

Big Pharma is once again taking a major interest in biosimilars. The latest big pharmaceutical player to show an interest is biopharmaceutical specialist Boehringer Ingelheim. The German-based company announced on 26 September 2011 that it would create a dedicated division for the development and commercialisation of biosimilars.

Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit

Biosimilars/News | Posted 30/09/2011

On 19 September 2011, and after years of conflict with FDA, Amphastar Pharmaceuticals (Amphastar) finally received approval to market a biosimilar version of sanofi-aventis’s blockbuster blood-thinner Lovenox (enoxaparin). The announcement, however, was closely followed by news that Momenta Pharmaceuticals (Momenta) had launched a lawsuit against Amphastar.

Generics and biosimilars affected by Obama’s deficit plans

Biosimilars/News | Posted 23/09/2011

US President Barack Obama’s plan for economic growth and deficit reduction, announced on 19 September 2011, recommends a series of healthcare reforms. The proposals include higher drug rebates for low-income patients, banning pay-to-delay deals between generics and originator companies and reducing biologicals exclusivity from 12 to seven years. The proposals aim to save US$320 billion in healthcare spending over 10 years.

Sanofi announces new long-term objectives

Biosimilars/News | Posted 23/09/2011

At a ‘strategy and outlook’ seminar for investors held on 6 September 2011, sanofi-aventis (sanofi) CEO Mr Christopher A Viehbacher commented on the group’s outlook. The group has undergone radical changes since 2008, when it was faced with losing several blockbuster drugs over a relatively short time period, the so-called ‘patent cliff’. The main action sanofi took was to buy biotech company Genzyme and thus gain access to the biosimilars, rare diseases and multiple sclerosis markets. However, other actions not so interesting to the media have also played a great part in the company’s repositioning.