Biosimilars
Caution over IP provisions for biologicals in TPP
The US Generic Pharmaceutical Association (GPhA) has expressed its concerns over negotiations currently taking place on the Trans-Pacific Partnership (TPP) agreement.
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).
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.
US approvals of biologicals doubled in last decade
Regulatory approvals for new biological drugs in the US have nearly doubled in the last decade compared with the 1990s, according to the May/June 2011 issue of the Tufts Center for the Study of Drug Development (CSDD) Impact Report. However, the author of the report, Research Assistant Professor Janice Reichert, said there are still ‘substantial challenges’ to be faced by biologicals manufacturers if they wish to ‘maintain that pace’.
Standards for biosimilars or ‘alternative’ biologicals in India
In the highly regulated market of the EU clear and rigorous guidelines exist for approval of biosimilars. In the EU biosimilars must ensure the same quality, safety and efficacy, as any other product, along with demonstrating biosimilarity (comparability) with the reference product.
More debate over the exclusivity period for biological in the US
The debate over the length of exclusivity that biological drugs can enjoy before competition from biosimilars ensues seems set to be a long and complicated one. The latest group to join in the debate is the Office of the US Trade Representative (USTR).
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.
Need for a global pathway for biosimilars
The need for access to biosimilars is global, yet the regulations are national. Issues with this approach are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].
Enoxaparin biosimilar or not
A biosimilar of the low molecular weight heparin, enoxaparin, produced by Sandoz (Novartis’s generics division) was approved by the FDA on 23 July 2010. However, some question whether this was really a biosimilar or not.
Interchangeability or substitution of biosimilars
The interchangeability or substitution of biosimilars is a subject that differs somewhat between Europe and the US. These different approaches to biosimilars are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].
