Newsletter - February 18, 2016
First Biosimilar with Extrapolation: Interchangeability is Next
This week FDA’s Arthritis Advisory Committee recommended approval of Remsima, a biosimilar product to Remicade. Remsima was developed by South Korea’s Celltrion. Remicade is one of Janssen’s biggest products with annual revenue of about $7 billion. There are several firsts in this decision. This is the first biosimilar to a monoclonal antibody reviewed by an FDA advisory committee and most likely will be the first biosimilar monoclonal antibody product approved by FDA. Read More..
Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?
Almost every week FDA make public announcements about dietary supplements with risky ingredients such as unapproved drugs, hidden drug ingredients, dangerous chemicals and other ingredients. FDA’s web-site lists more than 700 such dietary supplements that are sold in the US market. The list is published based on tests conducted at FDA’s labs. However, very few retailers and distributors of such dietary supplements are penalized despite laws that exist to do the same. Read More..
First Biosimilar with Extrapolation: Interchangeability is Next
This week FDA’s Arthritis Advisory Committee recommended approval of Remsima, a biosimilar product to Remicade. Remsima was developed by South Korea’s Celltrion. Remicade is one of Janssen’s biggest products with annual revenue of about $7 billion. There are several firsts in this decision. This is the first biosimilar to a monoclonal antibody reviewed by an FDA advisory committee and most likely will be the first biosimilar monoclonal antibody product approved by FDA. Read More..
Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?
Almost every week FDA make public announcements about dietary supplements with risky ingredients such as unapproved drugs, hidden drug ingredients, dangerous chemicals and other ingredients. FDA’s web-site lists more than 700 such dietary supplements that are sold in the US market. The list is published based on tests conducted at FDA’s labs. However, very few retailers and distributors of such dietary supplements are penalized despite laws that exist to do the same. Read More..
