Apotex Challenges Minister’s Refusal To Approve Apo-rasagiline
Apotex is seeking judicial review of a decision to decline to issue a Notice of Compliance (“NOC”) to Apotex for its Apo-rasagiline...Read More
Overrun by nettles: Government to prune the PM(NOC) Regulations
Industry Canada has announced its intention to amend the Patented Medicines (Notice of Compliance) Regulations. These proposed changes focus on the issue...Read More
US CAFC squelches patent for cloned sheep
The Court of Appeals for the Federal Circuit Court recently upheld the USPTO’s rejection of patent claims directed to cloned farm animals...Read More
Would a biologic by any other (nonproprietary) name smell as sweet?
One of the many contentious issues in the evolving U.S. biosimilar regulatory landscape regards whether 351(k) biosimilar products will have the same...Read More
FDA approves Teva’s tbo-filgrastim for severe neutropenia
On August 29, 2012, the U.S. FDA approved Sicor Biotech’s BLA for tbo-filgrastim (XMO2 filgrastim), to reduce the time certain patient receiving...Read More
Celltrion announces Korean approval of biosimilar monoclonal antibody
On July 23, 2012, Celltrion announced the approval by the Korean Food and Drug Administration of REMSIMA, its biosimilar anti-TNFα monoclonal antibody....Read More
Supplementary Protection Certificates for new uses – ECJ clarifies “first authorization of the product”
On July 19, 20120 the European Court of Justice (ECJ) rendered it decision in Case C-130/11 dealing with the availability of Supplementary...Read More
Genentech and U Penn settle HERCEPTIN patent suit
On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product...Read More
Merck Serono partners with Dr. Reddy’s on cancer biosimilars
On June 6, 2012, Germany’s Merck Serono, a division of Merck, announced a partnership with India’s Dr. Reddy’s Laboratories Inc. to develop...Read More
On your mark, get set, go! Biosimilar litigation takes off in Canada
On May 18, 2012, Amgen Canada Inc. and Amgen Inc. (“Amgen”) commenced a proceeding (Court File No. T-989-12) under the Patented Medicines...Read More
FDA’s biosimilar stakeholder submission roundup – Part IV
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 III
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 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