Imagine you are diagnosed with a difficult to treat chronic condition such as rheumatoid arthritis or Crohn’s disease. You’re prescribed a biologic drug, which effectively manages your symptoms, however creates a strain on your bank account. You quickly join countless Americans faced with making some difficult choices at a particularly vulnerable time — paying for essential treatment options, or foregoing such options due to the hardships it would cause.
Unfortunately, this challenge is common to many patients prescribed a biologic medicine. Biologic use is widespread — seven of the top 10 selling pharmaceuticals in 2015 were biologics. These therapies are effective and crucial; however, they are often costly. The price of the average biologic is more than 22 times that of a traditional pharmaceutical drug, due to significantly higher development costs. Current estimates find biologics at 40 percent of total prescription drug spending, anticipated to rise to over 50 percent by 2018. The sustainability of such spending for these important medicines is questionable. However, there is an answer.
By now many have likely heard of biosimilars, lower cost, equally as effective competitors to branded biologic drugs. Biosimilars reflect a mechanism and starting point to address the high cost of biologic medicines. Indeed, in September, the U.S. Food and Drug Administration approved the fourth biosimilar product. With over 50 additional biosimilars currently in the FDA review process, it is clear these drugs are not an ephemeral promise; they are a reality, albeit fledgling.
However, in the US, biosimilars are not getting to market quickly enough. The four biosimilars noted have required six years to approve after the passage of BPCIA, which created the biosimilar regulatory pathway in the US. Compare this with Europe who recently celebrated their 10th anniversary of the creation of their biosimilar pathway, with over 20 biosimilars approved, accumulating more than 400 million patient days of safe, effective biosimilar use. In order for biosimilars to reach full potential, the U.S. needs to support policies allowing these products to be developed without delay by artificial barriers, especially those influenced by brand companies.
One of the most significant barriers is the blocking of access to samples of a branded product required by the biosimilar developer in order to conduct the necessary scientific testing to gain marketing authorization from the FDA. In order to demonstrate biosimilarity, a biosimilar candidate must be directly compared to the branded product both analytically and clinically. Some brand companies have increasingly sought to impede sample access either through refusing to sell product to a biosimilar developer, artificially increasing prices, or through manipulation via company designed Risk Evaluation and Mitigation Strategy (REMS) safety protocols. This activity directly impedes biosimilar development ultimately limiting access to patients.
The bipartisan Creating and Restoring Equal Access to Equivalent Samples Act seeks to prevent these transgressions and ensure timely access to these reference products. If passed, biosimilar producers will have the ability to purchase the branded company reference product in order to conduct the necessary studies for biosimilar development. Should a branded company continue to restrict product availability, CREATES authorizes a judge to award damages for preventing access while offering court-supervised negotiations between brand and biosimilar producers. This reduces barriers by improving the efficiency for biosimilars to reach the market, creating competition, lowering costs and increasing patient access to these important biologic medicines.
The CREATES Act is not without its opponents — unsurprisingly many are on the branded product side. Challengers have claimed a number of objections. The first is that such legislation will increase costs for patients, arguing that brand companies will be forced to raise prices in order to pay for resulting litigation. This claim is misguided. As written, litigation is only to be utilized when a brand company hinders access to a product. Activity to limit access to samples seeks to impede competition, which delays market entry, preserving a monopoly by extending an already lengthy 12-year exclusivity period, and maintaining high prices. Instead, the Act would serve to increase competition by ensuring timely completion of essential studies, lowering costs for patients.
Opponents also argue that many biologics are administered under by a physician, and these often potent substances must be treated with care, calling into question the ability of a biosimilars producer to adhere to safety protocols. While it is factual that many biologics are administered under doctor supervision, the Act offers protection from liability for the brand company, shifting the requirement to follow established safeguards onto the biosimilar developer.
In fact, the legislation specifies the branded company and biosimilars developer must agree on the usage of the reference product, and the biosimilars developer must adhere to decided safety parameters defined in the REMS, which are established and applied to protect clinical trial subjects and subsequent users of the biosimilars. As noted, REMS are established as a means to protect patients and should not be manipulated as a means to restrict access. Indeed, the Food and Drug Amendments Act of 2007 specifically notes that brand name manufacturers shall not use their REMS to “block or delay approval” of a generic manufacturer product. While FDA reaffirmed this position in 2014, enforcement of such has been referred to the FTC. The CREATES Act allows for a judicial solution to a vexing problem preventing the development of products to increase patient access.
The CREATES Act is not the full answer to the challenging equation of providing affordable medicines to patients in need, but it is part of the solution. As written, the Act supports access to a reference product for biosimilar development, thereby expediting patient access to valuable medicines and encouraging the development of a robust biosimilars market.
We must establish policies that drive toward greater marketplace competition, in turn offering a greater number of products, increasing patient access and lowering costs. Such competition inherently encourages innovation, creating opportunities for new life-changing therapy options and preserving funding in the health care system to pay for these novel therapies through the reductions of costs of older drug options.
Dr. Bert Liang is the founding and current CEO of Pfenex Inc., a biologics company focused on providing access to biosimilars. Dr. Liang is the Chair of the Biosimilars Council, a division of the Generic Pharmaceuticals Association. Engage with him on Twitter @Bert_Liang.
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