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The field of biosimilars has been rapidly expanding in North America, providing a potential pathway for increased access to more affordable biological medicines. Biosimilars are highly similar copies of approved reference biologic products, designed to have comparable efficacy and safety profiles. However, ensuring patient safety and fostering competition while maintaining regulatory standards have been key challenges in establishing a robust biosimilar regulatory framework.
In North America, biosimilars are regulated by the U.S. Food and Drug Administration (FDA) in the United States and Health Canada in Canada. These regulatory agencies play a crucial role in evaluating the safety, efficacy, and quality of biosimilar products, ensuring they meet stringent standards before entering the market.
The biologics licence application (BLA) for Sandoz's denosumab biosimilar (GP2411) with a reference to Prolia/Xgeva was approved by the FDA for evaluation. If approved, the biosimilar will be used to treat both patients with treatment-induced bone loss and premenopausal individuals with osteoporosis who are at a greater risk of fractures. The denosumab candidate will also be utilised to treat malignancy-related hypercalcemia resistant to bisphosphonate therapy and to avoid skeletal problems in cancer that present or spreads to the bone.
The Biologics Price Competition and Innovation Act (BPCIA) of 2010 created the U.S. biosimilar pathway. According to the FDA, a biosimilar product must show that it is identical to the reference product in terms of safety, purity, and potency.
To gain approval, a biosimilar must undergo rigorous analytical, preclinical, and clinical testing to establish similarity and efficacy. The BPCIA also outlines an abbreviated licensure pathway for biosimilars, known as the 351(k) pathway, which allows reliance on existing data for the reference product.
The Food and Drugs Act and the Food and Drug Regulations govern biosimilars in Canada. Health Canada follows a science-based approach similar to the FDA, requiring comprehensive comparative data to demonstrate similarity to the reference product. The agency has established the Regulatory Framework for Biologic and Radiopharmaceutical Drugs (RFBRD), which outlines the requirements for the authorization of biosimilars.
One of the key considerations in biosimilar regulation is the interchangeability and substitution of biosimilars with their reference products. A biosimilar must satisfy additional conditions outlined by the FDA to be granted interchangeability status.
In Canada, interchangeability is determined by individual provinces and territories, as they have jurisdiction over drug reimbursement and substitution policies. Some provinces have implemented substitution policies, allowing pharmacists to automatically substitute a prescribed biologic with an interchangeable biosimilar, while others require physician authorization for substitution.
The majority of the time, Canadian policymakers have promoted the use of biosimilars through passive new start regulations, which demand that patients starting a biologic for the first time do so with a biosimilar as well, they continued. However, to maintain provincial drug coverage, the province of British Columbia became the first in North America to compel persons on treatment to transition to a biosimilar in 2019. Individuals receiving reference etanercept and infliximab for inflammatory arthritis and psoriasis were given six months to transition to the appropriate biosimilar under the first phase of these switching rules.
Samsung Bioepis, a leading biopharmaceutical company based in South Korea, recently announced in 2023 that Health Canada has approved its biosimilar product called Hadlima (also known as SB5). Hadlima is a formulation without citrate that has a high concentration of 40 mg/0.4 mL and was created as a biosimilar of the well-known medication Humira (adalimumab) from AbbVie. Ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn's disease, polyarticular juvenile idiopathic arthritis, and rheumatoid arthritis (RA) are among the inflammatory disorders for which Hadlima has been particularly prescribed. These conditions can cause significant discomfort and impairment to patients, and the availability of biosimilars like Hadlima provides them with an alternative treatment option.
Post-marketing surveillance is given top priority by the FDA and Health Canada to track the efficacy and security of biosimilars after they are put on the market. This ongoing monitoring helps detect any potential safety concerns, identify adverse events, and maintain public confidence in biosimilar products.
Another important aspect of biosimilar regulation is the naming and labelling of these products. In the United States, the FDA does not require distinct non-proprietary names for biosimilars, unlike the naming conventions for generic drugs. However, suffixes are added to the biosimilar’s non-proprietary name to ensure traceability. In Canada, biosimilars are given unique brand names, which helps differentiate them from the reference product and avoids confusion.
BioIntel360 emphasizes that regulations surrounding biosimilars in North America have evolved significantly in recent years to promote competition, enhance patient access to affordable biologics, and ensure their safety and efficacy. The FDA and Health Canada continue to refine their regulatory frameworks to address emerging challenges and encourage the development of biosimilars while maintaining high standards of quality and patient care.
