April 20, 2024
Remicade Biosimilars

Remicade Biosimilar Manufacturing and Regulation

Remicade (infliximab) is a biologic drug approved by the U.S. FDA in 1998 for the treatment of several autoimmune diseases like rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. As the patent for Remicade expired in 2014, several biosimilar versions of infliximab have emerged in the market.

What are Biosimilars?

A Remicade Biosimilar is a biologic medical product that is highly similar to an already approved biologic drug (known as the reference product). Biosimilars are developed to be similar but not identical to the reference biologic therapy, for which patent protection has expired. The minor differences in biosimilars are not expected to alter the safety, purity or potency of the product. Biosimilars are regulated by the FDA and EMA through a rigorous approval process to ensure they meet stringent standards for safety, purity and potency. Their development relies on extensive analytical, nonclinical and clinical studies comparing them to the reference product. If approved, biosimilars represent safe and effective treatment alternatives to the originator biologics.

Remicade Biosimilars Approved So Far

Three infliximab Remicade Biosimilars have received FDA approval till date – Inflectra (Pfizer), Ixifi (Sandoz) and Renflexis (Samsung Bioepis). These products are approved for all eligible indications of the reference drug Remicade. While Inflectra and Ixifi are already available in the U.S. market, Renflexis received approval recently in April 2020. All three biosimilars demonstrated similarity to Remicade in quality characteristics, biological activity, safety and effectiveness based on thorough step-wise analytical, nonclinical and clinical evaluation programs. Post marketing pharmacovigilance is employed to continuously monitor their safety profiles.

Biosimilar Manufacturing and Regulation

The manufacturing of biosimilars is highly complex owing to the biological nature of these products. Biosimilars are produced through living cell culture systems and require advanced purification techniques. Critical quality attributes of the molecule like glycosylation patterns need to match the reference product. Comprehensive analytical testing is conducted at each step of development and manufacturing to ensure consistency.
Biosimilars undergo a step-wise approval pathway managed by the FDA. It involves analytical, nonclinical and clinical studies aimed at establishing biosimilarity rather than independent safety and efficacy. The clinical trial endpoints focus on pharmacokinetic and pharmacodynamic outcomes along with immunogenicity and safety. Extrapolation of data to other indications of the reference product is allowed if biosimilarity can be sufficiently justified. This rigorous yet abbreviated pathway helps balance innovation and access considerations for these large molecule biologics.

Clinical Evidence for Remicade Biosimilars

All three Remicade biosimilars have presented robust clinical data demonstrating biosimilarity to Remicade. The key randomized controlled trials enrolling patients with rheumatoid arthritis found no clinically meaningful differences in terms of efficacy, safety, immunogenicity and pharmacokinetic outcomes when switching to a biosimilar versus continuing on Remicade. Data from ongoing observational studies have also not detected new safety signals. A recent meta-analysis concluded that switching to an infliximab biosimilar was well tolerated and maintained clinical outcomes comparable to the originator product. This provides physicians and patients confidence in switching to a cost-effective alternative once patent exclusivity expires.

Potential Cost Savings and Improved Access

The availability of multiple infliximab biosimilars is projected to bring about substantial cost savings to both public and private payers in the U.S. healthcare system. Estimates suggest the entry of these biosimilar competitors could reduce spending on infliximab by over $1.5 billion annually in the U.S. alone. These savings are expected to be passed on to patients through lower co-pays or premiums and help increase access to critical biologic therapies. With over 150,000 patients currently using Remicade in the U.S., biosimilars allow more patients to benefit from infliximab treatment who were previously financially unable to access this high-cost option. Overall, infliximab biosimilars represent an important step towards ensuring long-term sustainability of healthcare budgets and improving patient outcomes.

Remicade biosimilars approved in the U.S. till date have demonstrated comparable quality, safety and efficacy to the reference product through rigorous approval standards. Their widespread uptake has the potential to significantly reduce treatment costs without compromising care. Proper pharmacovigilance plans help maintain patient trust in these products. With their affordable prices, infliximab biosimilars serve to enhance access to biologic therapies and help control ever-rising healthcare expenditures in the country. As more biosimilars enter the market, they will play a key role in expanding treatment options for chronic inflammatory conditions in the future.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it