Biosimilars

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.

US approvals of biologicals doubled in last decade

Biosimilars/Research | Posted 10/06/2011

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

Biosimilars/Research | Posted 10/06/2011

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

Biosimilars/General | Posted 10/06/2011

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

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.

Need for a global pathway for biosimilars

Biosimilars/Research | Posted 06/06/2011

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

Biosimilars/General | Posted 06/06/2011

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

Biosimilars/Research | Posted 27/05/2011

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].

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.

Etanercept and quality attributes changes

Biosimilars/Research | Posted 27/05/2011

Quality changes in commercially available etanercept (Enbrel) were found by Sandoz researchers over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].