Biosimilars - The Future Of Biologics

Biologics have revolutionized treatment for many complex diseases like cancer, diabetes and autoimmune disorders. However, high development and manufacturing costs of biologics keep their prices elevated making them unaffordable for many patients. Biosimilars offer a solution to this challenge by providing near-identical copies of biologics at significantly lower costs once patents and exclusivities of reference products expire. With several major biologic drugs going off-patent in the coming years, the biosimilars industry is poised for strong growth that can improve access and affordability of life-saving treatments worldwide.

What are Biosimilars?

Biosimilars are biologic medical products that are highly similar to the reference biologic medicine or 'original biologic' which has already been authorized for use. Biosimilars are developed to be similar to their reference product which means they work in very similar way and have no clinically meaningful differences in terms of quality, safety and efficacy. Though biosimilars are similar, they are not generic copies of their reference products due to the inherent structural complexity of biologics. Biosimilars require robust analytical, preclinical and clinical evidence to demonstrate similarity with their reference product.

Development Process
The development process of a biosimilar is a rigorous multi-step procedure that can take 5-7 years and involves significant investments. It starts with extensive analytical characterization and preclinical testing to confirm similarity at quality, safety and efficacy levels with the reference product. If preclinical evidence is adequate, clinical studies are initiated involving a few hundred patients to demonstrate similar pharmacokinetics, pharmacodynamics, safety and efficacy compared to the reference product. Finally, once biosimilarity has been proven scientifically, regulatory approval is sought based on totality-of-evidence. Most regulatory agencies require biosimilars to fulfil a set of quality, non-clinical and clinical requirements before granting approval and market authorization.

Regulatory Pathways
Major regulatory bodies like US FDA, EMA and WHO have well-defined scientific guidelines and standards for approval of Biosimilars. Demonstrating biosimilarity rather than bioequivalence is key for approvals. US and EU follow a totality-of-evidence approach where biosimilarity is judged based on analytical, functional, animal and clinical data. Extrapolation of approvals across indications of reference product is allowed if requisite scientific justification is provided. Most countries also require biosimilars to have same international non-proprietary name suffix as reference biologic to distinguish their identity while approving for the same indications. Proper pharmacovigilance and post-marketing surveillance are important prerequisites.

Cost Savings and Improved Access

Biosimilars offer significant cost savings of 20-40% compared to their reference products bringing much needed affordability in biologic treatments. In the US, savings from biosimilars entry for top three biologics Humira, Enbrel and Remicade is estimated at over $54 billion by 2026. Similar savings potential exists in other developed and emerging markets as well. These lower costs allow for expansion of patient access by getting more patients on treatment as well as switching more patients to biosimilars where feasible. Improved access translates to better health outcomes for chronic diseases globally. Countries are implementing policies favoring automatic substitution and increased biosimilar uptake to realize potential savings.


Challenges and Barriers

Patenting thicket, pending patent litigations and the complexities associated with demonstrating biosimilarity have slowed down initial uptake of biosimilars specifically in the US, Japan and few other highly regulated markets. Naming conventions, labeling requirements and restrictiveness of payors also impacted early adoption in the US and EU. Lack of long term safety and immunogenicity data and physician reluctance to switch stable patients pose other challenges. Concerns around interchangeability and extrapolation across all indications still remain in some markets. Addressing stakeholder hesitancy through robust pharmacovigilance, scientific communication and competitive pricing strategies will help expedite biosimilar access. Concerted policy push and physician education efforts are further needed for transition from originator biologics to biosimilars.


With innovative biologic drugs transforming treatment landscapes, biosimilars provide an opportunity to enhance patient access to these revolutionizing therapies at more affordable prices. Fast adoption of biosimilars can play a significant role in sustainable healthcare spending and free up resources for innovation. While initial uptake challenges remain in developed markets, increased efforts around scientific clarity, improved policies and competitive business models will help realize enormous value of biosimilars. As patents of top biologics expire, the next decade holds immense potential for this important segment to come of age and address unmet medical needs worldwide in a highly cost-effective manner.

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