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FDA new drug approvals up in 2011: 900 biotech drugs in development

FDA had already approved 26 new drugs by the end of August 2011 compared to only 21 approved in 2010. Of note were six cancer drugs and two ground-breaking drugs for hepatitis C. The current year looks likely set a record for recent years for new drug approvals, which may total 35–40 by the end of 2011. After a slow start in the first two months with three new drug approvals and nine rejections in January and February 2011, FDA approved four new drugs, two of which were monoclonal antibodies, in March and five in April. Of the 11 new drugs approved in the first four months, only three biologicals were approved.

Biocon announces Malaysia manufacturing plant

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

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

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

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

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

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

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

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

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.

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