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.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Breaking Down Biosimilar Barriers: Payer and PBM Policies
November 13th 2024Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.