Biosimilars/News
Merck enters biosimilars deal with Korea’s Hanwha
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).
Lupin and Neuclone biosimilars agreement
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.
Positive results for phase I trial of biosimilar erythropoietin
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.
Stada and Richter to collaborate on biosimilar development
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.
China’s 5-year biotech investment fires clear warning to US
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].
Is FDA requesting too much data to allow biosimilars to succeed in the US
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].
EMA and FDA to collaborate on biosimilars
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.
Mylan re-brands Matrix Labs to enter Indian market
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.
Interchangeability of biosimilars in the US
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.
Biosimilars user fees as high as brand-name fees
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.
