Streamlined Tests May Lower Biosimilar Costs, Improve Patient Access

Quick summary

• Drugs are categorized into “small molecule drugs” (e.g., Disprin) and “biologics” (large, complex molecules like insulin and monoclonal antibodies).
• Small molecule drugs have fixed structures, while biologics can have slight variations due to being produced in biological systems.
• Patent protection on originator drugs prevents competitors from producing them for years; once off-patent, generics can lower drug costs significantly. Example: Hepatitis C drug Sovaldi dropped from $84,000 to $1,000 when Indian firms made generics.
• Biologics made by generic firms are termed “biosimilars,” as they cannot be identical to the original biologic drug due to differing production systems.
• Testing requirements for biosimilars are more elaborate compared to small-molecule generics, leading to higher approval costs. Regulators in the UK and US (e.g., FDA) aim to simplify approval processes by removing animal trials or introducing modern testing methods like organoids.
• In India, similar updates for biosimilar testing are under proposal but not formalized fully yet; some experts suggest adopting practices from the UK and US.
• Simplifying biosimilar tests while ensuring efficacy could make them more affordable for wider patient access.

Source Image Description: A supervisor inspects pre-filled syringes of a biosimilar at a Zydus Group facility in Gujarat | Photo Credit: AFP

Indian Opinion Analysis

The article highlights the critical importance of cost-effective medicines-especially biologic drugs-in India’s healthcare system where affordability remains crucial given economic disparities. While generic small-molecule drugs revolutionized global healthcare accessibility (as seen with sovaldi’s pricing shift), simplifying regulatory frameworks for biosimilars could similarly transform treatment availability for chronic diseases requiring advanced therapies.India’s cautious approach toward updating approval protocols contrasts with ongoing reforms in developed nations such as the UK and US-but emphasizes patient safety while balancing scientific advancements like organoid-based trials as potential replacements for animal studies or expensive clinical trials.

Adopting simplified yet stringent standards that align with affordability goals may position India both as a major innovator in global pharmaceutical manufacturing and ensure better accessibility domestically-a dual imperative given growing demand for cutting-edge treatments such as rheumatoid arthritis therapies mentioned via Zydus Group efforts shown.

Read More: The hindu – Simpler Tests Could Slash Biosimilar Costs