Two-for-One Deal – A Successor Second Person Can Adopt the Original NOA
The Federal Court dismissed a judicial review by Bayer Inc. and Regeneron Pharmaceuticals, Inc. of the Minister of Health’s decision allowing Biosimilar... Read More
Long-Term Safety Data ≠ Longer Patent List for STELARA
The Federal Court upheld a decision of the Office of Submissions and Intellectual Property that Canadian Patent No. 3,113,837 was not eligible... Read More
To Market, To Market, or the Regulations Will Not Apply
The Federal Court dismissed two applications for judicial review by AbbVie Corporation, who challenged the Minister of Health’s decisions (1) finding JAMP... Read More
Federal Court Holds Biologic Patent Valid and Infringed
In the first patent action involving biosimilars, the Federal Court held that the patent was valid and infringed. The Kennedy Trust for... 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
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
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
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
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
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