What are Biosimilar Drugs? Filgrastim-sndz was the first Biosimilar to be approved by the US FDA in 2015. There has been active participation by the Pharmaceutical majors in the US and other parts of the world since this first approval. It was even estimated that six out of ten top drugs or products could be Biosimialrs. They seemed to have clearly captured the imagination of the world of global pharmaceuticals as there are clear commercial advantages to bank on. Keeping the commercials and economics behind these drugs aside, there are clear patient related benefits in terms of access and cost of therapy. This provides a better purpose for many companies to participate in this segment while they continue to focus on long term research and new drug innovations.
Biosimilars are the drugs developed with their clinical outcomes and efficacy similar to the pre-existing biological products. These are referred as the reference products or drugs. Biosimilars are compared in relation with the reference drugs for their similarities when it comes to safety and efficacy. While their structural identities are not absolutely identical, their similarities are ideal replicas of the original product structure, with some variations. These variations or differences wouldn’t contribute to major differences in terms of their outcomes. This method of developing replica drugs would eventually expand the production capacity and provide the opportunity for more manufacturers to participate in the production of key drugs. Cancer care is one of the key segments that has been benefitting from these drugs for obvious reasons pertaining to the improved patient access.
Legal validity and constraints for Biosimilar Drugs
The Biologics Price Competition and Innovation Act (BPCIA) is the basis for the guidelines of Biosimilar drug approvals. US FDA also formulated its specifications in line which this law, which is in effect since 2010. According to the legal specifications, the Biosimilar should clearly be aligned with the reference drug or biological product. This is more specific in terms of their mechanism of action and administrative pathways. There cannot be any difference when it comes to the indications as well. The same is applicable for the parameters including dosage and strength. Overall, the clinical outcomes must be in expected lines with the reference product while the key mechanisms and pathways remain identical. The manufacturing facilities must also be duly accredited and the standards recommended by the FDA shall be maintained at every phase of production. Biosimilars should also fulfil the clinical trial requirements and must be backed by credible data for wide range assessment and peer reviews.
Dilemma for patients when choosing treatments based on Biosimilar Drugs
Patients all over the world make their choices based on the best medical advice available for them. It is also not new for the patients to make their assessment based on various other factors. The general sense shared by the medical fraternity is clearly in favour of drugs or products that expand treatment options while optimizing the cost. FDA approvals should give more confidence as they are backed by rigorous reviews and data validation. If the treatment outcomes are in expected lines while safety is not compromised, there shouldn’t be any hesitation for opting in favour of Biosimilar products.
