In April 2016, the British Biosimilars Association (BBA) launched as a new sector group of the British Generic Manufacturers Association (BGMA). Much like The Biosimilars Council and The Biosimilars Forum in the U.S., the BBA aims to promote understanding and use of biosimilars and encourage the development of biosimilar-friendly policies in the U.K. A few months after its launch in 2016, I spoke with its former chair, Tim deGavre, and wrote an article about the impact Brexit could have on the biosimilar industry, as well as what initiatives the BBA had in its sights to address the challenges facing the U.K. industry.
It’s hard to believe it’s been almost two years since I wrote these articles. In the meantime, both the BBA and the U.K. biosimilar space as a whole have continued to grow in a number of important ways. For one, Kavya Gopal, the head of the specialty business for Sandoz U.K., recently took over as chair of the BBA. Following her appointment as BBA chair, I was particularly excited to speak with Gopal (and welcome her onto the Biosimilar Development editorial advisory board) to get a closer look at the ongoing U.K. market challenges and the BBA’s progress.
Not only did the National Health Service (NHS) release its highly anticipated Commissioning Framework for Biological Medicines (including Biosimilar Medicines) in September 2017, but I continue hearing success stories about how payers are partnering with clinicians and pharmacists to make biosimilar uptake work. In addition, the NHS launched its national Cancer Vanguard program in 2015 to improve the availability and delivery of cancer treatments. As part of the Cancer Vanguard program, the Royal Marsden in London — one of the world’s leading oncology institutions — along with the Christie NHS Foundation Trust and University College London Hospitals, partnered with Sandoz to establish ‘Biosimilars: Getting It Right First Time’. Together, they established a ‘roadmap’ and supporting materials to help in the rapid adoption of biosimilar medicines. In the first of this three-part article, we touch on some of these developing topics, as well as what Gopal is keeping her eyes on in the U.K. (and globally).
Why The Rest Of The World Is Watching The FDA
In her role with Sandoz, Gopal is tasked with heading up the commercialization and adoption efforts for biosimilars. This involves managing the teams in the field that are speaking to clinicians, patient advocacy groups, the NHS, and other stakeholders to ensure they’re armed with appropriate (and accurate) biosimilar-related information. Because her position offers a front seat to advocacy- and policy-related efforts, Gopal is well-equipped to take over the helm of the BBA.
As she described, “In the BBA, we’re trying to ensure we have a sustainable, competitive biosimilar market. We play a role in shaping how NHS looks at the market and how they prepare for new biosimilars coming to market. Any company with a commitment to biosimilars would be trying to do the same thing, so, in a sense my two positions are parallel tracks.”
While Gopal’s work for Sandoz and with the BBA obviously keeps her close to the U.K. market, I found it interesting to learn that some of the developments she is watching most closely are U.S.-centric. But as Gopal pointed out, in this industry, the FDA’s decisions and legal happenings in the U.S. can have implications on the U.K. and EU markets. Take, for instance, the controversial interchangeability designation in the U.S. It’s unlikely the EMA will ever adopt its own interchangeability stance (which it left to the purview of each country). Regardless, interchangeability creates confusion outside of the U.S. because there are different global definitions of it. One of the more obvious differences is that, in the U.S., automatic substitution of the biosimilar at the pharmacy is linked with interchangeability, while in the EU, interchangeability and pharmacy-level substitution are not connected. In fact, though many of the EU nations have endorsed switching patients from the reference to the biosimilar, many do not have the legal basis for pharmacy-level substitution.
One of Gopal’s main concerns about the interchangeability guidance is the impact it will have on biosimilar education abroad. “What really piques my interest is the level of understanding amongst clinicians and different stakeholders,” she described. “If people don’t understand the differences between what interchangeability means in the U.S., the U.K., and the rest of the EU, it’s another challenge we have to address.”
U.K. Biosimilar Evolutions
On a more U.K.-centric level, there are obviously some pressing big-picture questions that will ultimately impact the evolution of U.K.’s pharmaceutical market. As the EMA prepares for its big move to Amsterdam, questions remain about what the U.K.’s relationship with the EMA will be. Though there’s much uncertainty about Brexit, Gopal remains optimistic the U.K. will find its way sooner than may be expected.
“I don’t think we’ll ever find ourselves getting to a point where we don’t have an answer,” Gopal shared. “I think we’ll know fairly soon in which direction we’re going to go. But I think as it works itself out, BBA and other pharmaceutical stakeholders are currently all trying to figure out what Brexit means for us.”
For instance, as she highlighted, Brexit poses the same questions for all pharmaceutical products, not just biosimilars, including what the evaluation of a pharma product will be. “The EMA process was great because you only had to do one filing,” she said. “It was one procedure across the board.” Now, it’s unclear if there will be different requirements to approve all drugs. When it comes to biosimilars, the BBA, in particular, is ensuring decision makers understand the implications of their decisions. One of the most crucial factors is that the regulatory approval process for biosimilars, which has been developed over many years and with significant input from the U.K. regulator, the MHRA, is currently undertaken by the EMA with no parallel approval process existing in the U.K. alone. In the U.K., biosimilars manufacturers are keen to have certainty from U.K. Government that EMA processes will still be followed, or that any new processes will be closely aligned to those of the EMA, following Brexit.
Outside of Brexit and its implications, a big development in the U.K. this year was the publication of the long-awaited Commissioning Framework for Biological Medicines (including Biosimilar Medicines). The framework lays out a period of time in which new and current biologics patients would be transitioned to the best value biologic once a biosimilar is launched. The goal is to have 90 percent of new patients prescribed the best value biologic within three months of a biosimilar launch. For patients already on a biologic, the goal is to see 80 percent switched within a year of the biosimilar’s market arrival.
What’s particularly interesting about the framework is that it uses the term “best value,” as opposed to “lowest-cost” or “cheapest.” As Gopal pointed out, this wording choice is particularly important given the industry’s goal to make biosimilars less about price and more about accessibility and value.
But the framework also raises an important question about the potential impact of biosimilars. As Gopal explained, the entrance of biosimilars could bring the price of the reference biologic down — perhaps even to the level of the biosimilar. Though this may not be the future the biosimilar industry had in mind, their presence on the market could, in some situations, lead to greater access to the originator. The framework itself does not take a stance on this, but by having biosimilars on the market, an originator can respond to that market change in different ways, including adjusting price.
There are a number of other initiatives underway to continue developing the U.K. biosimilar market. Over the past two to three years, acceptance and uptake of biosimilars have been quite positive. If you were to look at the market adoption curve, you’d find each subsequent biosimilar product released has a steeper curve over a much shorter period of time. “This is because the concept of biosimilarity is, for the most part, accepted in the U.K.,” Gopal said. “The NHS and other stakeholders broadly accept it. While there are still discussions about switching data, clinician and patient choice, and what constitutes value, the U.K. has moved quickly on the biosimilar opportunity. Now it’s just a matter of ensuring the appropriate uptake of each biosimilar that maximizes the positive impact for all stakeholders.”