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Biosimilars/News

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Hospira looks to biosimilars and increased use of generics for growth

Biosimilars/News | Posted 16/09/2011

Injectable generics leader, Hospira, announced on 7 September 2011 at its investor day, that it will look to biosimilars and international expansion for future growth.

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FDA gives some insight into biosimilar pathway

Biosimilars/News | Posted 12/08/2011

FDA has outlined some of the requirements it intends to include in its biosimilars approval process in an article published in the New England Journal of Medicine [1]. The article is intended to give drugmakers, investors and other interested parties more insight into the approval process for biosimilars.

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Partnerships will drive biosimilar development

Biosimilars/News | Posted 24/06/2011

With biosimilars tipped to become a multibillion-dollar market in the coming years, everybody is jumping on the biosimilars bandwagon, and it seems it’s not just limited to pharmaceutical companies.

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Does industry support biosimilar user fees in the US?

Biosimilars/News | Posted 24/06/2011

According to FDA, biopharmaceutical trade groups are supportive of its proposal for biosimilar user fees, with sponsors paying an up-front fee with their applications.

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Caution over IP provisions for biologicals in TPP

Biosimilars/News | Posted 17/06/2011

The US Generic Pharmaceutical Association (GPhA) has expressed its concerns over negotiations currently taking place on the Trans-Pacific Partnership (TPP) agreement.

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Merck enters biosimilars deal with Korea’s Hanwha

Biosimilars/News | Posted 17/06/2011

US pharma giant Merck announced on 13 June 2011 an exclusive deal with South Korea’s Hanwha Chemical Corporation to develop and commercialise a biosimilar version of Amgen and Pfizer’s blockbuster rheumatoid arthritis drug Enbrel (etanercept).

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Lupin and Neuclone biosimilars agreement

Biosimilars/News | Posted 10/06/2011

Indian generics manufacturer Lupin Pharmaceuticals has signed an agreement with Australian biotech firm NeuClone to access cell line technology to be used to develop biosimilar drugs targeting cancer.

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Positive results for phase I trial of biosimilar erythropoietin

Biosimilars/News | Posted 09/09/2011

Hospira, self-proclaimed leader in injectable generics, announced on 6 September 2011 positive results from a phase I clinical trial of its biosimilar erythropoietin (EPO) carried out in the US in patients with anaemia associated with chronic renal (kidney) failure and chemotherapy.

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Stada and Richter to collaborate on biosimilar development

Biosimilars/News | Posted 02/09/2011

German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter) announced on 30 August 2011 that the two companies have signed licence and collaboration agreements for the development and marketing of two biosimilars.

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China’s 5-year biotech investment fires clear warning to US

Biosimilars/News | Posted 26/08/2011

The Chinese Government has targeted biotechnology as a ‘strategic pillar’ industry, and has pledged to spend 2 trillion yuan (Euros 213. 3 billion; US$308.5 billion) on science and technology in the next five years alone [1]. This has sent out a clear warning to the US Government that China aims to become the world’s pioneer in biotechnology in the short to medium term. In response, despite being under increasing pressure to reduce overall health expenditure, the US Government has resisted calls to cut funding and pledged US$ 32 billion to its National Institutes of Health biomedical research programme for 2012 [2].

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Is FDA requesting too much data to allow biosimilars to succeed in the US

Biosimilars/News | Posted 26/08/2011

The FDA’s recently published plans for a biosimilar approval pathway are facing increasing scrutiny. In an interview with Scientific American, Novel Health Strategies’ biosimilar market entry advisor, Dr Saurabh Aggarwal, said that the level of data required by FDA is too much for biosimilars to be able to succeed [1].

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EMA and FDA to collaborate on biosimilars

Biosimilars/News | Posted 01/07/2011

The EMA announced on 23 June 2011 that it had set up a new ‘cluster’ to collaborate with the FDA for the exchange of information on biosimilar drugs.

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Mylan re-brands Matrix Labs to enter Indian market

Biosimilars/News | Posted 17/06/2011

US generics manufacturer Mylan announced on 27 May 2011 that it plans to rebrand its India-based subsidiary Matrix Laboratories as Mylan in order to launch its own prescription drugs in the emerging Indian market over the next year.

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Interchangeability of biosimilars in the US

Biosimilars/News | Posted 27/05/2011

As drug manufacturers await guidance on a biosimilar approval pathway in the US, the debate goes on as to how high the bar will be set for the FDA to designate a biosimilar as interchangeable. In one critical area of the law that outlines biosimilar regulations, Congress outlines the difference between biosimilarity and interchangeability with respect to biosimilars and innovative biologicals, but the FDA has yet to define the difference.

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Biosimilars user fees as high as brand-name fees

Biosimilars/News | Posted 13/05/2011

On 9 May 2011, the FDA proposed a user fee programme that would see drugmakers seeking approval to market biosimilars in the US initially paying fees similar to those required of originator biological drug developers.

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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.

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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.

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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.

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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.

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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.