Biosimilars/News
Biosimilar user fee levels and performance goals for the FDA
FDA and representatives from the drug industry negotiating a user fee for biosimilars have tentatively set performance goals and biosimilar user fee levels, creating a separate review programme for biosimilars.
Boehringer Ingelheim joins other Big Pharma going into biosimilars
Big Pharma is once again taking a major interest in biosimilars. The latest big pharmaceutical player to show an interest is biopharmaceutical specialist Boehringer Ingelheim. The German-based company announced on 26 September 2011 that it would create a dedicated division for the development and commercialisation of biosimilars.
Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit
On 19 September 2011, and after years of conflict with FDA, Amphastar Pharmaceuticals (Amphastar) finally received approval to market a biosimilar version of sanofi-aventis’s blockbuster blood-thinner Lovenox (enoxaparin). The announcement, however, was closely followed by news that Momenta Pharmaceuticals (Momenta) had launched a lawsuit against Amphastar.
Generics and biosimilars affected by Obama’s deficit plans
US President Barack Obama’s plan for economic growth and deficit reduction, announced on 19 September 2011, recommends a series of healthcare reforms. The proposals include higher drug rebates for low-income patients, banning pay-to-delay deals between generics and originator companies and reducing biologicals exclusivity from 12 to seven years. The proposals aim to save US$320 billion in healthcare spending over 10 years.
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.
