As often discussed, market entry of biosimilars, in general, brings a new hope not just for many patients, but also to biosimilar drug manufacturers – planning to get marketing approvals of these drugs in the United States, the El Dorado of global pharma industry.
Stakeholder expectations keep increasing manifold as biosimilars offer cheaper treatment options with biologic drugs in many life-threatening and rare diseases. However, biosimilars still remain an unfulfilled promise.
The January 2018 paper by Trinity Partners on “The State of US Biosimilars Market Access” in the largest drug market of the world makes an important observation in this regard. It says, the promise of biosimilars offering cost-saving competition in the lucrative US biologic market, remains largely unfulfilled.
As on date, adoption of biosimilars has been hindered by lack of market access due to complex contracting dynamics, besides regulatory and legal uncertainty, and a general lack of clinical comfort with biosimilars.
Consequently, current state of biosimilar acceptance and access appear too insignificant. More so, as compared to traditional small molecule generic markets where their use is fueled by automatic substitution and payer formularies, over higher priced branded reference drugs.
It would not have been difficult, especially for the innovative biologic drug makers to brush this important study aside, had the US-FDA Commissioner – Scott Gottlieb would not have voiced what he did in March this year.
With this perspective, I shall discuss in this article, how access to biosimilar drugs are getting limited. In doing so, I shall begin with what the US-FDA Commissioner has recently highlighted in this area.
Yet another barrier:
As reported by Bloomberg on March 07, 2018, the US-FDA Commissioner Scott Gottlieb unambiguously expressed that biologic drug manufacturers enter into exclusive arrangements with Pharmacy Benefit Managers (PBMs) and insurers, who agree to cover only the old brands in return for rebates or discounts. This “rigged” payment scheme might quite literally scare the biosimilar competition out of the market altogether, he articulated, categorically.
US-FDA Commissioner delivered this speech at the National Health Policy Conference for America’s Health Insurance Plans. During this deliberation, Gottlieb criticized some unwanted and avoidable practices that stifle biosimilar development.
He observed, of the 9 approved biosimilars in the US, only 3 could be launched market. In many instances, patent litigation is the reason for such delay in launch, post FDA approval. Connecting the dots, the Commissioner observed, even after being in the market, biosimilars continue facing more uncertainty due to a ‘rigged payment scheme.’
Started with a great promise:
It is worth noting, till 2010 no regulatory pathway for marketing approval of biosimilars was in place in the world’s largest pharma market – the United States. Hence, despite biosimilar drugs being a treatment option in many countries over the last two decades, the first biosimilar was launched in the US, following this pathway, only in 2015. It was Zarxio ((Filgrastim-sndz) of Novartis – indicated for the treatment of patients with acute myeloid leukemia (AML).
Since then, US-FDA has approved nine biosimilars. Ironically biosimilar market size still remains small and much below the general expectations. Most biosimilar manufacturers are navigating through multiple tough hurdles for market launch of this relatively new genre of complex drugs.
Navigating through tough hurdles:
There are tough hurdles to navigate through, while launching biosimilars, especially in the US. Some of which are as follows:
Protracted litigations: The development and launch of most biosimilars get stuck in the multiple patent web-lock, created around original biologic molecules, leading to long drawn expensive litigations.
Pricing: Following small molecule generic drugs, most payers and consumers expect biosimilar pricing too will be no different. However, in practice, most biosimilars are priced just around 15 percent to 20 percent less than original biologics.
Interchangeability: Lack of interchangeability among presently approved biosimilars in the US limits payers’ and consumer choice for a shift from the reference biologic drugs to suitable biosimilars. This virtually restricts the use of biosimilars mostly to such drug-naïve patients.
Confidence: For various reasons, the confidence and familiarity of both physicians and the consumers on biosimilars remain suboptimal. Whether relatively cheaper biosimilars can be used in the same indications as the reference biologic to the new patients – as an alternative choice, is still not clear to many of them. This situation calls for increasing awareness programs involving all stakeholders.
Manufacturing: The manufacturing process of large molecule biosimilars is quite costly as compared to small molecule generic drugs. Hence, these are unlikely to follow a similar pricing pattern, attracting as high a discount as around 80 percent, compared to original branded drugs.
Some of these barriers I have discussed in my article, titled ‘Improving Patient Access To Biosimilar Drugs: Two Key Barriers’, published in this blog on July 31, 2017.
Conclusion:
Be that as it may, drug manufacturers continue to see tremendous opportunity in biosimilars. The interest is heating up, as about six of the top 10 biologic drugs are expected to go off-patent in the US by 2019.
Despite all this, it is generally believed, the prevailing situation will change even in the US. The regulator is expected to facilitate smoother market entry of biosimilars, facing much less obstacles on the way. As many strongly believe, these are possibly an outcome of intense industry lobbying, with the high-level policy makers. Many of these hurdles can be removed by the regulators, themselves, including drug interchangeability.
The US-FDA Commissioner Scott Gottlieb has already said in a meeting on March 07, 2018, the FDA will start educating doctors and patients to minimize clinical and other concerns related to biosimilars. Therefore, going forward, greater competition in the biosimilar space is expected to increase the long-awaited price differential, as compared to reference biologic.
With greater support from the regulators, biosimilars still show a unique promise of greater acceptance and access to patients – occasionally ‘Rigged’ maneuvers by the vested interests notwithstanding.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.