Biosimilars/News

Biocon announces Malaysia manufacturing plant

Biosimilars/News | Posted 21/10/2011

Biocon, a global biopharmaceutical company with high-tech manufacturing and research arms, announced in September 2011 ‘project commencement for its first high-end biopharmaceutical manufacturing and R & D facility in Bio-XCell, Malaysia’ [1]. Malaysia, epitomised by the Bio-XCell biotechnology park, is considered ‘an ideal location to manufacture generics’ by industry analysts Frost & Sullivan.

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.