by The biopharmaceutical industry has seen tremendous growth and innovation over the past few decades. Large molecule biologics have revolutionized the treatment of diseases ranging from cancer to arthritis. However, biologics have also been very expensive due to the complex nature of their development and manufacturing. This is where biosimilars come into play. Biosimilars are biologic products that are highly similar to an already approved biologic reference product. They have no clinically meaningful differences from the reference product in terms of safety, purity and potency. With patent expirations of blockbuster biologics accelerating, biosimilars are poised to bring more treatment options and cost savings to global healthcare systems.
What are biosimilars?
A biosimilar is a biologic medical product which is developed to be similar to an already approved biologic product, known as the reference biologic product. Biosimilars offer significant cost savings compared to reference biologics without compromising on safety and efficacy. To be approved, a biosimilar has to go through a rigorous evaluation process by regulatory agencies like the FDA and EMA to demonstrate that it is highly similar to the reference product and there are no clinically meaningful differences between the two in terms of quality characteristics, biological activity, safety and efficacy based on comprehensive comparability exercise.
The development and approval process
While biosimilars are similar to generics, their development and approval process is more complex than generics due to the inherent structural complexity of biologics. Biosimilars are developed through a step-wise process – first analytical characterization techniques are used to show similarity at the molecular level between the biosimilar and reference product. This is followed by non-clinical testing in animal models and then clinical trials including PK/PD and efficacy/immunogenicity studies. Two key principles guide the clinical testing – extrapolation of indications and no need for clinical efficacy equivalence trials if biosimilarity has been established based on sensitive analytical and functional assays. This allows biosimilars to have similar labeling as the innovator biologic upon approval, including same therapeutic indications.
Benefits of biosimilars
Greater treatment access: By offering more affordable alternatives to costly biologics, biosimilars are helping to expand patient access to important treatments worldwide. Their lower cost makes these therapies more sustainable for national healthcare systems.
Generating cost savings: It is estimated that Biosimilars could provide potential savings up to $54 billion in the US alone over the next five years. This translates to massive savings for payers and reinvestment of resources in other areas of healthcare.
Stimulating competition: As biosimilar approvals increase each year, they start competing with reference products, generating market competition. This leads to lowering biologics prices through competitive market forces, benefiting both patients and payers.
Spurring innovation: The biosimilar user fee program opens pathways for faster approvals. This incentivizes investment in biosimilar development. Resources saved through biosimilars can also be redirected to support other areas of biomedical innovation.
Challenges Ahead
Intellectual property management: Patent thickets and evergreening strategies by innovators have delayed some biosimilar approvals and launches. Resolving IP litigations amicably is important.
Interchangeability determinations: Clear process and evidentiary standards are required to enable automatic substitution of biosimilars at pharmacy level like generic substitution. This supports optimal utilization and cost savings.
Physician acceptance and interchangeability: Education of physicians and reassuring them on biosimilarity, attribution and traceability is key for driving wider adoption particularly around interchangeable use.
Fostering trust among patients: Communicating scientific tenets and real-world evidence to build confidence among patients regarding biosimilars quality, safety and effectiveness will help accelerate their uptake.
Global harmonization: With several agencies now involved, ensuring consistent scientific and technical guidelines globally facilitate biosimilars development and help patient access worldwide.
Biosimilars present a major opportunity for global healthcare over the next decade. By increasing competition, injecting more therapeutics into the market and driving prices down, biosimilars have the potential to revolutionize patient access to expensive biologic treatments. With various opportunities and challenges ahead, concerted efforts by all stakeholders can help realize the promise of biosimilars through policies encouraging development, building trust and wider adoption in clinical practice. This will transform healthcare delivery worldwide making it more sustainable and equitable for all.
