Generics, Biosimilars Makers Join Global Medical Harmonisation Body

Doors to a global medical harmonisation organisation opened to the generic and biosimilar industry, which described it as an historical moment for them. The industry will now be able to sit on the assembly of the international body that joins regulators and the pharmaceutical industry.

At issue is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). According to a press release, the ICH‘s General Assembly today approved the International Generic and Biosimilar Medicines Association (IGBA) as an ICH assembly member. ICH is a Geneva-based organisation that brings together regulatory authorities and the pharmaceutical industry.

The decision reflects the evolution of the generic and biosimilar pharmaceutical industries, with generics accounting for the majority of the prescriptions filled globally,” while the development and approval of biosimilars and other complex-to-manufacture medicines continue to expand,” according to the release.

Biosimilar products, also called follow-on biological products, or similar biotherapeutic products, are defined by the World Health Organization as: “a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.”

Beata Stepniewska, deputy director general and head of regulatory affairs for Medicines for Europe, told Intellectual Property Watch in an email, “Our industry expresses a strong interest in a rational and harmonized approach to generic drug development and quality to ensure positive impacts to global public health.”

“We are willing to contribute to elaboration of those standards,” she said, “particularly in the areas being critical for generic medicines industry like harmonised international standards for bioequivalence studies, future development of quality standards (including on APIs, finished products, excipients, manufacturing and GMP) and future telematics standards that have an impact on electronic submission of Marketing Authorisation Applications.”

“To join the ICH as an Assembly Member is a historical moment for our industry,” IGBA Chair Vivian Frittelli said in the release. “We strongly believe that, having contributed to the ICH work as an interested party during the last 20 years, we can now open a new chapter of engaging fully in the ICH activities of developing the international standards applied to the pharmaceutical industry, including generic and biosimilar manufacturers.”

In October, the ICH, during the inaugural meetings of its new Assembly, announced organisational changes, and in particular aiming at making the ICG “a truly global initiative,” according to ICH.

“More involvement from regulators around the world is welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members,” said ICH. “This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonization.”