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It’s a whole new biosimilar world. In the April 2012 issue of GI & Hepatology News (GIHN) there was a small article on the issued Food and Drug Administration guidance on how to develop biosimilars. A biosimilar molecule must be structurally similar to the reference or originator product with the expectation that the safety and efficacy will be the same. The European Medicines Agency (EMA) established a legal framework for approving biologics in the European Union in 2003 and guidelines for approval in 2005 to 2006 with the first biosimilar approved in 2006 (somatropin [Omnitrope]).
The first monoclonal antibody biosimilar approved by the EMA was CT-P13 (infliximab-dyyb) in June 2013. There are now over 23 biosimilars approved for use in Europe. In 2012 there were no biosimilars on the market in the United States. This past year (2016) has been the year of the biosimilar with two of the four approved compounds used in inflammatory bowel disease – Inflectra (infliximab-dyyb, Hospira) April 2016 and Amjevita (adalimumab-atto, Amgen) September 2016 appearing.
The launch of these biosimilars raises a whole new series of questions. First and foremost for gastroenterologists – are the biosimilars truly similar in patients with inflammatory bowel disease? Adalimumab-atto was approved on the basis of two phase III studies in psoriasis and in rheumatoid arthritis and infliximab-dyyb was approved on the basis of studies in rheumatoid arthritis and ankylosing spondylitis. Other questions arise: 1. Can a patient who is doing well on the originator be safely switched to the biosimilar? 2. Can we use the same assays for drug monitoring? 3. Will use of biosimilars lead to a lower cost structure for patients and hospitals? 4. What are the regulations and guidelines for interchangeability? (GIHN March 2017) In the United States, development of biosimilars was slow to start but we expect to see an explosion in development of these agents in gastroenterology as the patents expire on the biologics currently in use.
Kim L. Isaacs, MD, PhD, is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. She is codirector of the UNC Center for Inflammatory Bowel Disease. She is an Associate Editor for GI and Hepatology News.
It’s a whole new biosimilar world. In the April 2012 issue of GI & Hepatology News (GIHN) there was a small article on the issued Food and Drug Administration guidance on how to develop biosimilars. A biosimilar molecule must be structurally similar to the reference or originator product with the expectation that the safety and efficacy will be the same. The European Medicines Agency (EMA) established a legal framework for approving biologics in the European Union in 2003 and guidelines for approval in 2005 to 2006 with the first biosimilar approved in 2006 (somatropin [Omnitrope]).
The first monoclonal antibody biosimilar approved by the EMA was CT-P13 (infliximab-dyyb) in June 2013. There are now over 23 biosimilars approved for use in Europe. In 2012 there were no biosimilars on the market in the United States. This past year (2016) has been the year of the biosimilar with two of the four approved compounds used in inflammatory bowel disease – Inflectra (infliximab-dyyb, Hospira) April 2016 and Amjevita (adalimumab-atto, Amgen) September 2016 appearing.
The launch of these biosimilars raises a whole new series of questions. First and foremost for gastroenterologists – are the biosimilars truly similar in patients with inflammatory bowel disease? Adalimumab-atto was approved on the basis of two phase III studies in psoriasis and in rheumatoid arthritis and infliximab-dyyb was approved on the basis of studies in rheumatoid arthritis and ankylosing spondylitis. Other questions arise: 1. Can a patient who is doing well on the originator be safely switched to the biosimilar? 2. Can we use the same assays for drug monitoring? 3. Will use of biosimilars lead to a lower cost structure for patients and hospitals? 4. What are the regulations and guidelines for interchangeability? (GIHN March 2017) In the United States, development of biosimilars was slow to start but we expect to see an explosion in development of these agents in gastroenterology as the patents expire on the biologics currently in use.
Kim L. Isaacs, MD, PhD, is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. She is codirector of the UNC Center for Inflammatory Bowel Disease. She is an Associate Editor for GI and Hepatology News.
It’s a whole new biosimilar world. In the April 2012 issue of GI & Hepatology News (GIHN) there was a small article on the issued Food and Drug Administration guidance on how to develop biosimilars. A biosimilar molecule must be structurally similar to the reference or originator product with the expectation that the safety and efficacy will be the same. The European Medicines Agency (EMA) established a legal framework for approving biologics in the European Union in 2003 and guidelines for approval in 2005 to 2006 with the first biosimilar approved in 2006 (somatropin [Omnitrope]).
The first monoclonal antibody biosimilar approved by the EMA was CT-P13 (infliximab-dyyb) in June 2013. There are now over 23 biosimilars approved for use in Europe. In 2012 there were no biosimilars on the market in the United States. This past year (2016) has been the year of the biosimilar with two of the four approved compounds used in inflammatory bowel disease – Inflectra (infliximab-dyyb, Hospira) April 2016 and Amjevita (adalimumab-atto, Amgen) September 2016 appearing.
The launch of these biosimilars raises a whole new series of questions. First and foremost for gastroenterologists – are the biosimilars truly similar in patients with inflammatory bowel disease? Adalimumab-atto was approved on the basis of two phase III studies in psoriasis and in rheumatoid arthritis and infliximab-dyyb was approved on the basis of studies in rheumatoid arthritis and ankylosing spondylitis. Other questions arise: 1. Can a patient who is doing well on the originator be safely switched to the biosimilar? 2. Can we use the same assays for drug monitoring? 3. Will use of biosimilars lead to a lower cost structure for patients and hospitals? 4. What are the regulations and guidelines for interchangeability? (GIHN March 2017) In the United States, development of biosimilars was slow to start but we expect to see an explosion in development of these agents in gastroenterology as the patents expire on the biologics currently in use.
Kim L. Isaacs, MD, PhD, is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. She is codirector of the UNC Center for Inflammatory Bowel Disease. She is an Associate Editor for GI and Hepatology News.
