MS Experts in Latin America Publish Recommendations for Biosimilar Policies

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:

• Strictly apply current regulations for biosimilar products and complex nonbiological molecules in order to guarantee the quality, efficacy, and safety of drugs used for the treatment of MS
• Develop mechanisms that allow the traceability of products prescribed for MS
• Avoid what the authors call “uncontrolled interchangeability”
• Implement a strong pharmacovigilance program that allows the detection of safety problems associated with the use of original and biosimilar drugs
• Conduct national and Latin American studies that can demonstrate the differences, if there are any, in the safety and efficacy profiles of original and biosimilar drugs for the treatment of MS
• Prioritize protecting patient well-being and safety regarding economic aspects associated with the availability of pharmaceutical products.
• Educate healthcare professionals on issues that allow them to conduct an adequate and evidence-based selection and prescription of original biological and biosimilar products to patients with MS

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.