Innovation in Mexico - part 1

Last month?JackLeckerman?had the privilege to welcome? Sonia Mayra Pérez Tapia (General Director - UDIBI )?who took part in Biosimilars LatAm - Mexico 2022 hosted in Cancun. In her session of: Innovation in Mexico shared some very interesting insights about #biosimilars progresses, regulations and authorisations.

When it comes to the topic of Innovation in Mexico and the whole role of UDIBI in this matter, we decided to divide this information in various chunks of articles that will be published in the following weeks.

Biosimilars in Mexico (part 1)

EVOLUTION OF THE MEXICAN REGULATION FOR BIOSIMILARS IN THE PAST YEARS

BIOSIMILAR POLICIES EVALUATED ACROSS NINE KEY POLICY AREAS:

1. Manufacturing and R&D

• Local manufacturing incentives
• Manufacturing exemption waivers

2. Pricing and reimbursement

• Automatic reimbursement following regulatory approval
• Full coverage or partial coverage
• Exclusionary contracts
• Mandatory discounts for biosimilars and/or originators
• Tiered price discounts for subsequent biosimilar products
• Progressive price discounts, applied over time
• Reference pricing (both internally and internationally)

3. Health technology assessment

• Exemption from HTA requirements
• Simplified assessments

4. Monitoring

• Post-commercialisation pharmacovigilance measures
• Transparency in usage reporting
• Monitoring of product ability to supply

5. Regulatory Approval

• Streamlined evidence requirements
• Simplified regulatory approval through international collaboration
• Regulatory support for biosimilar submission

6. Biosimilar education and understanding

• Healthcare professional (HCP) and pharmacist educational programs
• Patient educational programs

7. Dispensing

• Automatic substitution
• Regressive retailer markups
• Reduced patient co-payments

8. Contracting

• Direct contracting with providers
• Tendering procedures

9. Prescribing

• Clinical recommendations for prescriber-initiated prescription of biosimilars
• Mandated switching
• Prescription quotas for volume of biosimilar prescription
• Financial incentives linked to volume of biosimilar prescription
• Financial penalties linked to volume of biosimilar prescription
• International non-proprietary name (INN) prescribing

POLICIES OBSERVED ACROSS COUNTRIES IN SCOPE

Don't forget that there is a continuation to this article where we will be deep-diving into the role of UDIBI when it comes to biosimilars. Coming out in the following weeks.

*All the information in this article was collected during Biosimilars LatAm - Mexico (November 2022) and is a property of Sonia Mayra Pérez Tapia (General Director - UDIBI)