Four institutions from three different continents now constitute the initial EBPMN Board: Chairman: Patrick Tippoo, representing Biovac (South Africa), Secretary: Tiago Rocca, representing Instituto Butantan (Brazil), Mrs. Meng Li, representing the China National Biotec Group Company Limited: CNBG (China) and Dr. Rajinder Suri, representing Panacea Biotec (India).
EBPMN adopted a constitution in 2019 and has established a framework and workplan to guide its activities in 2020. Formally established as an international non-profit association in The Netherlands, the EBPMN Secretariat is temporarily hosted by UCAB, with the intention to transfer it to another neutral country as soon as the Network matures.
Enhance access to biopharmaceuticals by facilitating local manufacturing capacity in Low- and Middle-Income Countries.
To achieve its mission, the Network aspires to become a recognized global platform for public private collaborations between emerging biopharmaceutical manufacturers in LMICs and WHO, regulatory agencies, nongovernmental organizations, academic institutions, biotech and service providers.
The Network is to benefit its members by providing updated information on new developments in the field of biotherapeutics, in particular biosimilars. These developments include strategic, scientific, technical and commercial developments and opportunities, with an emphasis on the formation of product development partnerships (PDP’s) including joint development and commercialization and technology transfer.
The annual EBPMN forum will become an excellent opportunity to learn about the latest developments in process development technologies, evolving regulatory pathways and new commercial opportunities to forge partnerships and product development consortia in the global health space. Entry into the space of biosimilars may be a particular attractive business model for (vaccine) companies with an already existing production infrastructure and technological know-how to serve national, regional or global markets.
The UCAB experiences in existing product development partnerships and liaising with WHO and EMA regarding regulatory pathways to obtain international market authorizations to obtain may serve as an attractive cooperative model. By sharing experiences and mapping mutual synergies LMIC companies may decide with the help of facilitating entities such as UCAB (or other NGO’s) to take on one or more products for immediate development and commercialization. When the network matures, it will serve as a platform for members to speak with one voice, thus gaining influence in the global health arena.
Biotherapeutics: Biosimilars and others
Biopharmaceuticals, in particular biosimilars, are rapidly becoming critical health intervention tools in the global health space; increasingly in low- and middle-income countries. In fact, emerging markets have become ‘blue oceans’ for biosimilars and the high growth rate in the uptake of biologics in emerging markets represents a major opportunity for those companies developing biosimilars.
Development and manufacturing of biosimilars in those LMICs however still lags behind due amongst others to unfamiliarity with the new and rapidly changing regulatory landscape and recent scientific and technological developments which on the one hand have led to the emergence of various international operating service providers in the CMC and process development landscape, but which are on the other hand not yet optimally exploited in LMICs themselves.