With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.
With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.
As in other regions, the expanding use of biosimilars is due to interest in reducing costs, promoting the sustainability of healthcare systems, and improving patient access.
The Latin American Forum of Experts in Multiple Sclerosis gathered experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela to discuss good practices and risks associated with the use of biosimilar drugs and to develop a set of recommendations as the market expands.
Each country was assessed on its approval of biosimilar drugs by regulatory agencies, use of biosimilar drugs, pharmacovigilance plans and risk management strategies, and knowledge of the latest different molecules.
The availability of MS drugs varies by country and is thus far limited to biosimilar interferons and glatiramer acetate or glatiramoids and other disease-modifying agents, including natalizumab, alemtuzumab, and ocrelizumab.
Original immunomodulatory drugs used for MS treatment have already lost their patents and newer drugs will lose their patents within the next 10 years.
However, every nation’s approval and regulatory process is different; moreover, not every country has pharmacovigilance programs that includes adverse event reporting in the post-marketing phase.
Biosimilars are in use in Argentina, Colombia, Ecuador, Mexico, and Peru, and are expected to expand to other countries in the region.
Brazil is considered to have one of the more advanced regulations regarding biosimilars, as is Argentina, a major manufacturer in Latin America. Other countries, such as Bolivia, are still developing regulations. Countries such as Chile, Mexico, and Venezuela, where foreign exchange controls are in place, are expected to expand.
The Latin American Forum of Experts in Multiple Sclerosis, an independent forum for reaching consensus about MS issues, recommends that each country:
Reference
Steinberg J, Fragoso YD, Duran Quiroz JC, et al. Practical issues concerning the approval and use of biosimilar drugs for the treatment of multiple sclerosis in Latin America [published online May 24, 2019]. Neurol Ther. doi: 10.1007/s40120-019-0139-y.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.