Advancing Biosimilar Development: STADA Shares Insights at CPHI

With almost 20 years of experience in biosimilars since the launch of its first biosimilar in 2008, STADA is among the pioneers in bringing competition to original biological medicines. Biosimilars can help broaden patient access to important treatment options while supporting the sustainability of healthcare systems.

The Role of Biosimilars at STADA

Biosimilars are an important part of STADA's Specialty business and its commitment to expanding access to high-quality medicines.

Over the years, STADA has steadily expanded its biosimilars portfolio, including monoclonal antibodies such as adalimumab, aflibercept, bevacizumab, denosumab, epoetin zeta, golimumab, pegfilgrastim, ranibizumab, teriparatide, tocilizumab, and ustekinumab. This development reflects STADA's growing expertise in complex biological medicines and its continued investment in the Specialty segment.

Advancing Biosimilar Access at CPHI

At CPHI Worldwide, a major international pharmaceutical industry event, STADA's Vice President of Global Specialty Development, Dr Christine Berndt, shared insights into the evolving biosimilars landscape and the potential impact of regulatory developments on patient access.

As Chair of the Biosimilar Medicines Sector Group at Medicines for Europe, Christine discussed how advances in analytical technologies and evolving regulatory approaches could help streamline biosimilar development.

Under certain conditions, these approaches may reduce the need for comparative clinical efficacy studies while maintaining rigorous standards for quality, safety and efficacy.

More efficient development processes could help bring additional biosimilars to market, including in areas where development has previously been challenging. This could foster competition, strengthen supply reliability and expand patient access to biological medicines.

What are Biosimilars?

A biosimilar is a biological medicine that is highly similar to an already approved biological medicine, known as the reference medicine.

Biosimilars are subject to rigorous regulatory standards for pharmaceutical quality, safety and efficacy. They play an important role in expanding treatment options and supporting sustainable healthcare systems.

Further information is available from the European Medicines Agency (EMA).