Biosimilars/News
Sanofi announces new long-term objectives
At a ‘strategy and outlook’ seminar for investors held on 6 September 2011, sanofi-aventis (sanofi) CEO Mr Christopher A Viehbacher commented on the group’s outlook. The group has undergone radical changes since 2008, when it was faced with losing several blockbuster drugs over a relatively short time period, the so-called ‘patent cliff’. The main action sanofi took was to buy biotech company Genzyme and thus gain access to the biosimilars, rare diseases and multiple sclerosis markets. However, other actions not so interesting to the media have also played a great part in the company’s repositioning.
Hospira looks to biosimilars and increased use of generics for growth
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.
FDA gives some insight into biosimilar pathway
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.
Partnerships will drive biosimilar development
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.
Does industry support biosimilar user fees in the US?
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.
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).
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.
