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Interchangeability V18K30

ANVISA updates understanding on biosimilar interchangeability

Home/Policies & Legislation | Posted 22/07/2026

Brazilian health regulator issues Technical Note 60/2026, reinforcing safety of product switching and potential for healthcare cost savings

The Brazilian Health Regulatory Agency (ANVISA) has published Technical Note 60/2026, updating its position on the interchangeability of biosimilar medicines. The document, prepared by the General Office of Biological Products (GGBIO), consolidates scientific evidence and international experience, concluding that switching between biosimilars and their comparator biological products does not significantly alter safety, efficacy, or immunogenicity profiles when performed according to approved usage conditions.

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China's 12th VBP round accelerates shift to generics and biosimilars dual-track

Home/Policies & Legislation | Posted 03/07/2026

China’s government has initiated enterprise submissions for its 12th national Volume-Based Procurement (VBP) batch, signalling an intensive new phase in its campaign to restructure healthcare costs. Run by the National Healthcare Security Administration (NHSA), this June 2026 procurement round places an estimated RMB 60 billion (US$8.8 billion) market up for grab across 65 critical drug varieties, aggressively accelerating the mandatory substitution of off-patent originators with low-cost generics and biosimilars.

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House Bill aims to crack down on China biotech deals

Home/Policies & Legislation | Posted 22/06/2026

A bipartisan House bill proposed on 2 June 2026 would require government screening of US investments in Chinese biotechnology, following two pharmaceutical deals potentially worth more than US$10 billion each.

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Costa Rica opens consultation on biological medicines registration and control reform

Home/Policies & Legislation | Posted 24/04/2026

The Costa Rican Ministry of Health has initiated a 60-day public consultation period on proposed amendments to Executive Decree No. 37006-S of 15 November 2011 [1, 2], which establishes the regulatory framework for the registration and control of biological medicines under ‘RTRC 440: 2010’ (Reglamento de Inscripción y Control de Medicamentos Biológicos).

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China updates regulations to encourage research and innovation and improved drug safety

Home/Policies & Legislation | Posted 04/03/2026

On 31 December 2025, China’s State Council announced a revision of Regulation for the Implementation of the Drug Administration Law, which is expected to encourage research and innovation in the country. This revision aims to strengthen the legal foundation for ensuring high-level drug safety and supporting the high-quality development of the nation’s pharmaceutical industry.

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Brazil and Mexico forge alliance to streamline medical approvals and boost production

Home/Policies & Legislation | Posted 09/02/2026

Brazil and Mexico have forged a dual regulatory and production alliance to streamline medical product approvals and boost regional manufacturing capacity for critical health technologies.

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EU accepts results from FDA GMP inspections for sites outside the US

Home/Policies & Legislation | Posted 27/01/2026

On 1 October 2025, the European Medicines Agency (EMA) announced a significant enhancement to the existing Mutual Recognition Agreement (MRA) with the US Food and Drug Administration (FDA). As a result, EU regulators will be able to voluntarily rely on FDA inspections of manufacturing sites outside the US when assessing human-medicinal-product applications and relevant variations [1]. 

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WHO to remove animal tests and establish 17 reference standards for biologicals

Home/Policies & Legislation | Posted 07/01/2026

October 2025 saw the 81st meeting of the World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) held from 13 to 16 October in Tunis, Tunisa (and virtually) [1].

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New direction for health regulation in Mexico

Home/Policies & Legislation | Posted 05/12/2025

Mexico's health regulator, Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS, has embarked on a profound modernization to drastically cut approval times, aiming to become a globally recognized benchmark for efficiency and innovation.

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Argentina streamlines drug approval process

Home/Policies & Legislation | Posted 13/11/2025

Argentina's National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) has streamlined drug approvals, reducing review times to accelerate market access for new medicines while upholding safety and quality standards.