Biosimilars are emerging as a viable treatment option for many chronic diseases. One of the blockbuster drugs that has seen increased competition from biosimilars is Remicade, which is used to treat several autoimmune conditions. Remicade is the brand name for infliximab, which was first approved by the FDA in 1998 to treat Crohn's disease. Since then, it has gained approval for other diseases like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. With the expiry of Remicade's patents, several biosimilar versions have entered the market providing more treatment choices. This article discusses Remicade biosimilars and their role in making biologic therapy more accessible and affordable.
What are Biosimilars?
Biosimilars are biologic medicines that are developed to be similar to an already approved biologic drug, known as the reference product. Biosimilar development involves a rigorous process to demonstrate likeness with the reference product in terms of safety, purity, and potency. While biosimilars are not generic copies, they are approved based on demonstrating that there are no clinically meaningful differences from the reference product. The regulatory standards ensure that switching between the reference product and its biosimilar is safe for patients.
Remicade Biosimilars Approved So Far
The first Remicade Biosimilars version of infliximab was approved in Europe in 2013 under the trade name Inflectra. Since then, several other infliximab biosimilars have been approved globally and in the US. Some of the key Remicade biosimilars approved so far are:
- Inflectra (infliximab-dyyb): Approved by EMA in 2013 and FDA in 2016, manufactured by Celltrion.
- Renflexis (infliximab-abda): Approved by EMA in 2017 and FDA in 2017, manufactured by Samsung Bioepis.
- Ixifi (infliximab): Approved by EMA in 2017, manufactured by Pfizer.
- Avsola (infliximab-axxq): Approved by FDA in 2017, manufactured by Amgen.
- Zessly (infliximab): Approved by EMA in 2018, manufactured by Sandoz.
All these products demonstrate biosimilarity to Remicade and provide safe and effective treatment alternatives for conditions where Remicade is indicated. Their availability has expanded treatment access worldwide.
Driving down Healthcare Costs
One of the major goals of biosimilar development and approval is to make biologic therapy more affordable. Biologics like Remicade are often very expensive injectable drugs used for chronic diseases. The high cost of biologics is a barrier for many patients who cannot afford the treatment. Biosimilars offer the same clinical benefit as the reference product but are priced significantly lower, typically 15-30% lower than the reference biologic. The cost savings from biosimilars are helping to make biologic treatment more sustainable for healthcare systems. In markets where biosimilars are available, their uptake has resulted in considerable healthcare savings. For example, the UK health system saved over $1 billion between 2017-18 due to increased biosimilar prescribing. Wider availability and adoption of biosimilars will ensure more patients have access to vital treatments while easing the rising healthcare expenditure.
Biosimilar Uptake in the US Market
The US currently has three approved infliximab biosimilars - Inflectra, Renflexis, and Avsola. Despite approval since 2016, their uptake in the US market has been slow compared to other markets like Europe. Barriers such as restrictive reimbursement policies, misinformation about the products, and confusion among physicians have stunted the biosimilar penetration in the US so far. However, there is now a growing momentum to drive the appropriate substitution and uptake of the cost-saving biosimilars. The WHO has released guidelines on the interchangeability of biosimilars, and interchangeably is now permitted in most states. Increasing awareness among stakeholders about the rigorous approval process, safety, and cost benefits of biosimilars should help accelerate their adoption in the US. Substituting Remicade with biosimilars could potentially save billions annually for the US healthcare system. Wider access to biosimilars will support the fiscal sustainability of public healthcare programs like Medicare and Medicaid.
The critical role of biosimilars in expanding global access to cutting-edge biologic therapy cannot be overlooked. As the first biosimilar wave matures, these products are demonstrating equivalence to reference biologics while offering cost-savings for healthcare systems. Steady progress in biosimilar guidelines and policies worldwide will continue to drive their appropriate use. This will benefit patients through more treatment choices and ensure more people receive life-enhancing modern medicines. Biosimilars signify a new era of biologic innovation that balances innovation and affordability to transform lives.
For more insights, Read- https://www.marketwebjournal.com/remicade-biosimilars-trends-size-and-share-analysis/
