On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH as an Assembly Member.  For the first time, an association representing generic and biosimilar companies is now able to sit at the table with regulators and pharmaceutical companies more traditionally on the innovator spectrum.

According to Intellectual Property Watch, Beata Stepniewska, Deputy Director General and Head of Regulatory Affairs for Medicines for Europe said in an e-mail to Intellectual Property Watch about the appointment:

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, 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.

In IGBA’s press release yesterday, IGBA Chair Vivian Frittelli added:

To join the ICH as an Assembly Member is a historical moment for our industry.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.  The IGBA is very much looking forward to playing a constructive role in the ICH, engaging actively in the ICH processes through the representation of our members across five continents.

ICH announcement follows organizational changes addressed in its October 2015 meeting.  Along those lines, ICH said it aims to be:

 [A] truly global initiative, expanding beyond the current ICH members. 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.

We previously blogged on this issue back in August 2014, when IGBA (formerly known as IGPA, the International Generic Pharmaceutical Alliance) had been denied membership on ICH’s Steering Committee.  While it was unclear then why IGPA had been denied membership in the Steering Committee, IGPA had sought membership because it believed that generic manufacturers should join as a full Steering Committee member to help improve pharmaceutical quality, safety, and efficacy, recognizing the global presence of generic medicines.  At that time, IGPA argued that ICH was about to enter its third decade, and so ICH should shift to recognize that ICH’s guidelines impact not only innovator but generic manufacturers.  IGPA pointed out, for example, that generic pharmaceuticals account for over 50% of the prescriptions filled globally and over 84% of the prescriptions filled in the United States.  IGPA added then that some ICH guidelines apply only to generic pharmaceuticals and biosimilars.

ICH’s increasing globalization and inclusion of IGBA represents a historic moment for innovator and generic and biosimilar companies to sit at the same assembly to develop internationally-applied guidelines that apply to all pharmaceutical companies. ICH began back in 1990, with regulators from the United States, Europe, and Japan as its primary members, along with each country’s innovator pharmaceutical trade organizations.  Other countries, such as Canada and Switzerland, were initially observers to the process, as IGBA has been, and are now members.  New information about how parties may become a member of ICH may be found here.

IGBA was founded as IGPA in 1997 to strengthen cooperation between associations representing manufacturers of generic medicines.  IGPA includes drug trade associations in the United States (Generic Pharmaceutical Association (GPhA), Canada (Canadian Generic Pharmaceutical Association (CGPA)), Europe (Medicines for Europe), Jordan (Jordonian Association of Pharmaceutical Manufacturers (JAPM)), Japan (Japan Generic Medicines Association (JGA)), South Africa (National Association of Pharmaceutical Manufacturers (NAPM)), and Taiwan (Taiwan Generic Pharmaceutical Association (TGPA)).  In addition, generic medicines associations from Australia, Brazil, Malaysia, and Mexico and are associate members.  According to IGPA, through its constituent member associations, the IGPA maintains constant dialogue with the European Commission for Europe, ICH, the World Trade Organization (WTO), the World International Patent Organization (WIPO) and the World Health Organization (WHO).

This historic decision reflects the global nature of generic and biosimilar product development and comes on the heels of IGBA’s successful Annual Meeting held last week in Croatia along with Medicines for Europe (formerly known as EGA, European Generic and Biosimilar Medicines Association), which represents generic, biosimilar, and value-added medicine companies in Europe.  IGBA said it looks forward to participating in the ICH Assembly and playing a constructive role in the Management Committee in the future, as envisioned in the new ICH structure.