COFEPRIS Biosimilar Approval: What You Need to Know About 2024 Guidelines

Key Takeaways

• Four-year plan: COFEPRIS announced a comprehensive strategy on February 9, 2024, covering immediate actions through medium-term reforms to strengthen Mexico's biosimilar sector.
• Production focus: The strategy includes creating a National Pharmaceutical Development Council to boost domestic manufacturing of biosimilars and innovative biologics.
• Regulatory alignment: Reforms target updates to NOM-177-SSA1-2013 (interchangeability) and the Regulations for Health Supplies (RIS) to reduce approval timelines.
• Recent approvals: In July 2024, COFEPRIS approved two Zydus biocomparables—bevacizumab (Bhava) and trastuzumab (Mamitra)—expanding oncology treatment options.
• Market gap: Mexico trails US and European biosimilar adoption, with the WHO identifying 17 policy areas needing strengthening in COFEPRIS guidelines.

What Is COFEPRIS's 2024 Regulatory Strategy?

On February 9, 2024, COFEPRIS Commissioner Alejandro Svarch Pérez unveiled the Estrategia de Certidumbre Regulatoria para el Sector Farmacéutico: Biosimilares (Regulatory Certainty Strategy for the Pharmaceutical Sector: Biosimilars). The announcement came via COFEPRIS Communication 17/2024.

The strategy covers the entire product lifecycle over four years. Immediate actions focus on regulatory clarity. Short-term measures include process streamlining. Medium-term goals target structural reforms. A key proposal is creating the Consejo para el Desarrollo Farmacéutico Nacional (National Pharmaceutical Development Council) to coordinate industry growth.

What Regulations Govern Biosimilars in Mexico?

Mexican biosimilar oversight relies on two main legal instruments. The Reglamento de Insumos para la Salud (Regulations for Health Supplies, RIS) provides the foundational framework. NOM-177-SSA1-2013—published September 20, 2013, in the Diario Oficial de la Federación—establishes tests and procedures to prove interchangeability.

NOM-177 specifies requirements for:

• Authorized third parties conducting interchangeability tests
• Biocomparability study protocols
• Research centers and hospital institutions performing biocomparability testing

The 2024 reforms aim to revise these standards to reduce administrative burden while maintaining safety standards.

How Does Mexico Compare to Other Markets?

Mexico's biosimilar market remains less developed than comparable jurisdictions. According to Biologics Policy comparison data, COFEPRIS guidelines score 2.3 out of 5 on WHO alignment—indicating partial compliance with international standards across 28 measured policy components.

Seventeen policy areas show gaps compared to WHO guidance. These include scope specificity, reference product requirements, formulation standards, and stability study protocols. The WHO analysis notes COFEPRIS does not require head-to-head stability studies comparing biosimilars to reference products—unlike more stringent jurisdictions.

By contrast, the US biosimilar market reached $38 billion in invoice spending facing biosimilar competition by 2023, with recent launches achieving high volume shares per FDA biosimilar tracking. An additional $96 billion in biologic spending is targeted by biosimilars in development or approved but not yet launched.

Which Biosimilars Has COFEPRIS Approved?

COFEPRIS has approved biosimilars across multiple therapeutic areas, with recent activity accelerating:

Recent COFEPRIS Biosimilar Approvals

Product	Reference Molecule	Sponsor	Approval Date	Indications
Bhava	Bevacizumab	Zydus (India)	July 2024	mCRC, NSCLC, breast cancer, glioblastoma, RCC, ovarian
Mamitra	Trastuzumab	Zydus (India)	July 2024	HER2+ breast cancer, gastric cancer
Rituximab biosimilar	Rituximab	Various	Pre-2016	Rheumatoid arthritis, NHL, leukemia

The July 2024 Zydus approvals mark significant expansion in oncology biosimilars. Bevacizumab inhibits vascular endothelial growth factor A (VEGF-A), blocking angiogenesis in tumors. Trastuzumab targets HER2-overexpressing cancers. Both products are available in standard concentrations: bevacizumab at 100 mg/4 mL and 400 mg/16 mL.

What Changes Are Expected for Manufacturers?

The 2024 reforms create both opportunities and requirements for biosimilar developers. Streamlined processes aim to reduce time-to-market. Clarified intellectual property exemptions should reduce legal uncertainty. Updated interchangeability criteria under NOM-177 may facilitate pharmacist substitution.

For originator biologic manufacturers, increased competition threatens market share. The FDA biosimilar experience shows biosimilars can capture significant volume within 12–18 months of launch when substitution policies are favorable. Mexican manufacturers may benefit from the proposed National Pharmaceutical Development Council's support for domestic production.

What Is the Outlook for Mexican Biosimilars?

Analysts expect accelerated approvals over the next 3–5 years as COFEPRIS implements its four-year strategy. Key developments to monitor include:

1. Publication of revised NOM-177 implementing regulations
2. Formation of the National Pharmaceutical Development Council
3. Additional approvals from Indian, Korean, and domestic manufacturers
4. Alignment with FDA and EMA standards through international harmonization
5. Expansion of therapeutic coverage beyond oncology to immunology and endocrinology

The success of these reforms will depend on COFEPRIS maintaining technical capacity while processing increased application volumes. Addressing the 17 identified WHO policy gaps would strengthen international confidence in Mexican biosimilar approvals.

Frequently Asked Questions

Primary Sources

1. COFEPRIS. "COFEPRIS da a conocer estrategia de certidumbre regulatoria para medicamentos biosimilares." Communication 17/2024. February 9, 2024.
2. Diario Oficial de la Federación. "NOM-177-SSA1-2013: Que establece las pruebas y procedimientos para demostrar que un medicamento es intercambiable." September 20, 2013.
3. GaBI Online. "COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables." September 18, 2024.
4. Biologics Policy. "Mexico Biosimilar Policy Assessment." Accessed 2024.
5. IQVIA Institute. "Biosimilars in the United States 2023-2027: Competition, Savings, and Sustainability." 2023.
6. Health and Pharmaceuticals Bulletin. "México. Cofepris da a conocer estrategia de certidumbre regulatoria para medicamentos biosimilares." May 2024.