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Biosimilars/News

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Indian Transgene sells biosimilar to German TSS Export

Biosimilars/News | Posted 09/12/2011

India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin (rh-EPO) to TSS Export GmbH FZE, part of the Germany-based TSS group, for US$5 million (Indian Rupees 260 million).

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National Psoriasis Foundation declares biosimilar stance

Biosimilars/News | Posted 02/12/2011

One of the leading psoriasis patient associations in the US, the National Psoriasis Foundation, has publically declared its stance on biosimilars. In an open letter to FDA, the Foundation issued a statement on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009 [1].

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Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture

Biosimilars/News | Posted 02/12/2011

Japanese Fujifilm Corporation announced on 16 November 2011 that it is once again making an agreement in the biosimilars field, this time with biotech firm Kyowa Hakko Kirin, Tokyo, Japan.

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New Amgen Enbrel patent could block biosimilars until 2028

Biosimilars/News | Posted 25/11/2011

Amgen announced on 22 November 2011 that it had been granted a new US patent on its blockbuster drug Enbrel (etanercept).

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Acino grabs Cephalon’s Middle East and African business

Biosimilars/News | Posted 25/11/2011

Switzerland-based generics company Acino Pharma announced on 14 October 2011 that it had agreed to buy biopharmaceutical company Cephalon ’s combined Middle East and African business in a transaction worth approximately Euros 80 million.

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Natco snaps up biosimilars: signing deal with Mabxience

Biosimilars/News | Posted 18/11/2011

Indian generic drugmaker Natco Pharma announced that it had entered into an exclusive agreement with Mabxience, the biosimilar division of Swiss firm Chemo Sa Lugano, on 19 September 2011.

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Battle rages over anti-thrombotic medicine

Biosimilars/News | Posted 10/11/2011

Sandoz/Momenta are ahead again in the fight for the lucrative anticoagulants market in the US. According to IMS Health data enoxaparin sodium injection is the best-selling hospital medicine in the US, and has been described as the ‘gold standard’ for anti-thrombotic treatments. Lovenox, sanofi-aventis’ reference product, recorded US sales of US$2.7 billion in 2009 and has been used to treat an estimated 200 million patients worldwide since it was launched.

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US$1 billion for cancer R & D

Biosimilars/News | Posted 04/11/2011

GE Healthcare, the health business of General Electric, provides advanced cancer diagnostic and molecular imaging capabilities, as well as technologies for the manufacture of biopharmaceuticals and for cancer research. Its presence at the European Multidisciplinary Cancer Congress 2011 in Stockholm indicated its commitment to strengthening cancer diagnosis and care. Similarly at the 53rd Annual American Society for Radiation Oncology Meeting in Miami Beach, Florida, USA, it was showcasing a number of new tools designed specifically for the needs of radiation oncologists.

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

Biosimilars/News | Posted 07/10/2011

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.