Policies & Legislation
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
This article examines the evolving regulatory landscape for simplified requirements for interchangeable biosimilars in the US. It explores recent US Food and Drug Administration (FDA) approvals, the role of switching studies, and updated labelling guidance, highlighting key changes and their implications for biosimilar development and use.
China’s NMPA expands global ties with Netherlands and Indonesia
China’s National Medical Products Administration (NMPA) has met with leaders from the Netherlands and Indonesia to discuss potential collaborations with these countries.
Japan's PMDA expands influence with new office in Thailand
On 1 July 2024, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) announced the establishment of its first overseas office, the PMDA Asia office. This office is now open in Bangkok, Thailand, and is headed by Dr Kitahara Jun.
Panama embraces international pharmacovigilance standards
Panama is implementing internationally standardized reporting codes for pharmacovigilance by adopting WHODrug Global and MedDRA dictionaries, following the example of several other Latin American and Caribbean countries.
FDA proposal to remove biosimilar interchangeability status in FY25
In a major shift in regulatory policy, the US Food and Drug Administration (FDA) is calling on Congress to remove the interchangeability designation that has historically set biosimilars apart in the US market. Backed by the Biden administration, the FDA's new proposal would permit pharmacy-level substitution of biosimilar drugs for reference products without clinician recommendation. This would extend to all approved biosimilars, regardless of their interchangeability status.
MHRA unveils strategy for regulating AI technologies
In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a policy paper on its strategic approach to artificial intelligence (AI) [1]. It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023 [2] and is the agency’s response to the Secretary of State letter of 1 February 2024 [3].
Regulatory Certainty Strategy for biosimilars launched in Mexico
In February 2024, Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.
Strategic plans of ANVISA and COFEPRIS to advance health regulation
ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition, identification of medicinal products (IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.
Panama enacts new bill to guarantees the supply of medicines
On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved in the third debate Bill 1007, which regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions were enacted.
EMA concept paper towards a tailored clinical approach in biosimilar development
In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'.
