Did you know that biosimilars account for less than 0.5% of the value of the mature markets biologic spend---but in pharmerging markets, non-original biologics are over 10% of all biologics spend?
According to a report by the IMS Institute for Healthcare: The Global Use of Medicines: Outlook through 2017, and are expected to represent 19-20% of the total market value in 2017. Other insights in the market:
• Biologics growth is driven by Monoclonal Antibodies (MABs) and human insulin, with four out of the top five biologics in 2012 being MABs.
• Development and production of biologics, both branded and generic, is increasingly competitive with a broad range of players, from small to large pharma companies now attracted to the market.
• In many countries with less rigorous IP protection laws, there has been a recent surge of non-original biologics (NOBs).
• The price premium typically associated with biologics has turned them into an obvious target for government savings in some markets. Connsequently, biosimilar pathways have been defined in Europe, US, and increasingly in pharmerging markets in an effort to encourage lower cost competition.
• In pharmerging markets, both governments and patients struggle to pay for biologics and hence NOBs, encouraged by market demand and government policy, have grown very quickly.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Sintilimab, Bevacizumab Biosimilar, HAIC Improves Survival in Patients With Unresectable HCC
April 14th 2024Positive results of sintilimab, IBI305, and hepatic arterial infusion chemotherapy (HAIC) treatment showed shrinking tumors and previously converting inoperable hepatocellular carcinoma (HCC) to resectable HCC with manageable adverse effects.