Biosimilars

Teva grabs biopharmaceutical company Cephalon

Biosimilars/News | Posted 06/05/2011

On 2 May 2011, Teva and Cephalon announced that they had unanimously approved a definitive agreement under which Teva will acquire all outstanding shares of Cephalon for US$81.50 per share in cash, or a total enterprise value of approximately US$6.8 billion.

Biobetters rather than biosimilars

Biosimilars/General | Posted 06/05/2011

‘Biobetters’, rather than biosimilars, are the next big opportunity for biopharm and contract research organisations (CROs) hoping to profit from patent expirations on biologicals, say experts.

Worldwide biosimilar development

Biosimilars/Research | Posted 29/04/2011

The limited access to high-quality biologicals due to the cost of treatment constitutes an unmet medical need in the US and other regions of the world [1].

Generics manufacturers and biosimilars

Biosimilars/News | Posted 29/04/2011

According to a report by the Wall Street Journal on 31 January 2011, generic manufacturers are expecting biosimilars to be the next cash cow, with sums in the multibillions of dollars expected to be reaped from this market in the near future.

Pharmacodynamic response of biosimilar filgrastim

Biosimilars/Research | Posted 22/04/2011

Research published online on 10 March 2011 on the pharmacodynamic response of recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim has shown that there is no difference between biosimilar and originator G-CSF.

The history of the US biosimilar regulatory pathway

Biosimilars/General | Posted 22/04/2011

The US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act [BPCI Act], which was signed into law on 23 March 2010 by President Barack Obama), does not yet have a practical pathway with guidance defined by the FDA.

Immunogenicity of biosimilar low molecular weight heparins

Biosimilars/Research | Posted 22/04/2011

In a presentation by Professor JM Walenga and colleagues from the Loyola University Medical Center, Illinois,USA, 'immunogenicity issues faced by biosimilar low molecular weight heparins (LMWHs)' were discussed [1].

Comparison of US and European biosimilar regulatory pathways

Biosimilars/Research | Posted 15/04/2011

The EU and the US have some differences in the way they approach biosimilars. Some of these differences were outlined in an article by Mr David Rosen and Mr Larry Lian published on 2 March 2011.

Biosimilar low molecular weight heparins in Brazil

Biosimilars/Research | Posted 15/04/2011

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Agência Nacional de Vigilância Sanitária, Anvisa) is fully satisfied with their quality, efficacy and safety. Likewise for biosimilars it is necessary that the biosimilar be equally effective and safe and without contaminants in relation to the originator medicine.

Everybody jumping on the biosimilars bandwagon

Biosimilars/News | Posted 08/04/2011

According to a report by Reuters on 13 January 2011, Big Pharma is taking a major interest in the biosimilars market. During interviews with Amgen, Merck, and Biogen Idec at the JP Morgan’s 28th Annual Healthcare Conference in San Francisco, USA, biosimilars was the hot topic.

Global biosimilar market to grow to US$3.7 billion in 2015

Biosimilars/General | Posted 08/04/2011

According to a report by Datamonitor published on 23 February 2011 the global biosimilars market will grow from US$243 million in 2010 to US$3.7 billion in 2015.

Boehringer Ingelheim acquires Amgen biotech site

Biosimilars/News | Posted 08/04/2011

Boehringer Ingelheim, one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals, announced on 25 March 2011 that it had formally acquired Amgen’s biopharmaceutical development and manufacturing facility in Fremont, California, USA.

Further lobbying over biosimilars

Biosimilars/News | Posted 01/04/2011

Brand-name drug companies are trying to weaken a provision of the US Patient Protection and Affordable Care Act that was designed to open up generic competition in biotechnology medicines and save billions of dollars. The industry, patients and providers are watching closely to see how the FDA will interpret the law, in documents that are expected to be released during late 2011.

Ongoing monitoring of biosimilar G-CSF (filgrastim)

Biosimilars/Research | Posted 25/03/2011

Sandoz is carrying out ongoing studies to ensure the safety of its biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim G-CSF). The MONITOR-GCSF study will recruit at least 1,000 patients from a minimum of 75 centres and follow them for a maximum of six cycles of chemotherapy.

Are biosimilars an easy option for big money

Biosimilars/General | Posted 25/03/2011

With the recent JP Morgan 29th Annual Healthcare Conference 2011 in San Francisco, US came a chance for reporters to quiz all the big name firms in one easy sweep. The result reported by Reuters is that the pharma industry is poised to dive into biosimilars.

Samsung to enter biosimilars market

Biosimilars/News | Posted 25/03/2011

Everybody is jumping on the biosimilars bandwagon these days, and it seems it is not just limited to pharmaceutical companies. Contract research organisation, Quintiles, announced on 28 February 2011 that it has entered into a deal with electronics giant Samsung to provide biologicals manufacturing and biosimilar development.

Biosimilar substitution in the EU

Biosimilars/Research | Posted 04/03/2011

Although many things—including regulations for licensing of biosimilars—are harmonised within the EU, the attitude towards biosimilars and their substitution within the different countries of the EU varies widely.

Spectrum to develop biosimilar monoclonal antibody

Biosimilars/News | Posted 04/03/2011

California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s blood-cancer drug Rituxan (rituximab).

Biosimilars boost for South Korea

Biosimilars/News | Posted 25/02/2011

The South Korean Government has pledged to promote the biosimilars industry and plans to invest in the biosimilars industry in order to make Korea a market leader. The government will provide both financial and institutional support and is aiming to take a 22% share of the global market by 2020.

Gedeon Richter sign biosimilars’ agreement with Mochida

Biosimilars/News | Posted 11/02/2011

On 14 December 2010 Budapest-based Gedeon Richter and Tokyo-based Mochida Pharmaceutical (Mochida) announced that the two companies have entered into a comprehensive and long term license and collaboration agreement with respect to development and marketing of Richter’s biosimilar product portfolio.