FDA’s biosimilar stakeholder submission roundup – Part II
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
FDA’s biosimilar stakeholder submission roundup – Part I
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
PM(NOC) guidance document updated to address cross-referenced drug submissions
On April 2, 2012, Health Canada issued an updated guidance document on the Patented Medicines (Notice of Compliance) Regulations. In particular, section...Read More
EMA publishes new procedural advice document for biosimilar applicants
The European Medicines Agency (EMA) has published a new document providing procedural advice for users of the centralised procedure for biosimilar product...Read More
AstraZeneca and Amgen team up to develop five human monoclonal antibodies
AstraZeneca and Amgen have announced an agreement to jointly develop a portfolio of Amgen’s clinical stage human monoclonal antibodies. The antibodies subject...Read More
Fujifilm / Kyowa Kirin joint venture to make biosimilar adalimumab
On March 27, Fujifilm Corporation and Kyowa Hakko Kirin Co. Ltd. announced the commencement of business operations for their joint venture, Fujifilm Kyowa...Read More
GSK and Genentech settle Cabilly patent lawsuit
GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech’s Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents. In...Read More
Apotex sues FDA over import alert
On February 29, 2012, Apotex brought a request for arbitration at the International Center for Settlement of Investment Disputes seeking damages under...Read More
India Grants First Patent Compulsory License
On March 9, 2012, the Indian Controller of Patents granted Natco Pharma’s application for a compulsory license thereby permitting it to market...Read More
Pfizer scraps alliance with Biocon for biosimilar insulin and insulin analog products
In October 2010, Pfizer and Biocon announced an alliance to develop biosimilar insulin products. On March 12, 2012, the partnership ended, with...Read More
Roche teams up with Emcure for Indian oncology mAbs
According to the Ecomonic Times, Roche has teames up with Indian manufacturer Emcure Pharmaceuticals to produce rituximab and trastuzumab for the Indian...Read More