Navigating the Complexities of Generics and Biosimilars in Portugal

By Danélia Botes

December 5, 2023

The Role and Mission of APOGEN

APOGEN, or the Portuguese Association of Generics and Biosimilars Medicines, is a non-profit organisation founded in 2003. Representing pharmaceutical companies in the Portuguese market, APOGEN’s mission is to promote the concepts of generic and biosimilar medicines. They establish dialogues with stakeholders, including the government and policy makers. They advocate for a more competitive pharmaceutical market.

The Importance of a Thriving Generics Industry

The significance of a thriving generics industry cannot be overstated. However, the introduction of unsustainable cost containment measures has led to product and company withdrawals from the market. This has highlighted the need for greater awareness of the risk of industry unsustainability.

Overcoming Roadblocks to Greater Generic Penetration

Despite generics penetration standing at 51 percent in units and 64.7 percent in the competitive market, Portugal still has significant potential for growth. Barriers such as doubts about the quality and efficacy of generics among doctors, and the pricing and reimbursement system, need to be addressed.

The Future of Generics and Biosimilars in Portugal

Biosimilar medicines offer increased access to life-altering biologic therapies. Although Portugal has implemented measures to facilitate the entry of biosimilar medicines, concerns remain about measures that could compromise the maintenance and launch of new biosimilars in the country.

The EU Pharma Package and APOGEN’s Aspirations

The recent proposal for amending the Pharmaceutical Directive and Regulation signifies a positive move towards the reform of EU pharmaceutical policy. APOGEN urges co-legislators to endorse policies that increase the uptake of generic, biosimilar, and value-added medicines. Therefore, they should also promote timely competition. It’s essential that the adjustment of incentives offers legal certainty for applications of generic and biosimilar medicines.

Bringing Essential Medicine Manufacturing Back to Europe

In conclusion, the outsourcing of essential medicine manufacturing to Asia has proven problematic during times of crisis. Portugal, with its highly skilled workforce and competitive labour costs, could play a crucial role in bringing essential medicine manufacturing back to Europe. 

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