The Brexit Rollout From the Biosimilars Perspective – The Center for Biosimilars

Brexit, the United Kingdoms official exit from the European Union after nearly half a century, has brought new challenges for the biopharmaceutical industry and, for those based in the United Kingdom, the potential for regulatory reforms that enhance their business opportunities, according to Maria Manley, LLM, a London-based partner with Sidley Austin and a widely respected expert on the life sciences.

In an interview with The Center for Biosimilars, Manley discussed the complex regulatory and business restructuring adaptation to the new Brexit landscape, the significance for biosimilars producers, and the British governments goals for this new arrangement.

A lot of pharmaceutical companies had to make significant changes to the way they were operating in the United Kingdom and in the European Union, she said. For example, companies that wanted to continue marketing their products in the European Union had to make sure the corporate entities holding European marketing authorization for products were properly domiciled, so they had to transfer their marketing authorization from the UK entity into an EU entity. Packaging labels had to be changed, too, and clinical trials had to be managed differently, among other changes.

No Tariffs or Quotas

Although it was costly and complicated for the corporate sector, Brexit meant certain advantages also. It led to a free trade agreement with no tariffs and no quotas, and an accord was reached on product certification and good manufacturing practice (GMP) inspection between the United Kingdom and European Union. The acceptance of natural recognition of GMP inspection and certification are obviously very important to the industry because they avoid duplication and extensive cost, she said.

What still represents a problem for companies that do business across national boundaries is the Northern Ireland Protocol, a subsection of Brexit that allowed Northern Ireland, which is part of the United Kingdom, to continue following some EU rules. This affected the movement and border checks of goods from Great Britain into Ireland. Two sets of legislation apply: one to what we call Great Britain [Wales, England, Scotland], and another one to Northern Ireland, and this is a complete nightmare to the industry, Manley said.

Despite the stress and complexity of Brexit, there has been minimal effect on the supply of drugs, and this is partly because the United Kingdom has temporarily acknowledged marketing authorizations previously granted to drugs in the European Union, which makes it possible for continued distribution in the United Kingdom. Affected companies have a period of 1 year to submit the essential [clinical/regulatory] baseline data to the regulatory body, the Health Research Authority, and to establish a presence in the United Kingdom if they didnt have it, and that is until January 2023, Manley said.

Life Sciences Investment

Protecting the interests of the pharmaceutical sector in the United Kingdom was paramount because not only do patients need continuity of quality health care, but the life sciences sector in the United Kingdom employs 260,000 individuals and contributes $41 billion annually to the local economy, Manley said. Having been an essential EU partner for so many years, the United Kingdom needs to make sure that they offer a legal environment that stimulates both innovation and also investment.

There remains close alignment between the UK and EU regulatory systems for biological products, according to Manley. However, the United Kingdom and its Medicines and Healthcare products Regulatory Agency (MHRA) have simplified the legal framework for biologics and biosimilars companies to apply for marketing authorization. In the United Kingdom, the new guidance and legislation make animal toxicology studies unnecessary for biologics developers, as these studies are rarely considered necessary, and comparative clinical efficacy studies will not be required unless there are very good reasons for doing them.

The new approval pathway for biologics is designed around accelerating the progress to market for experimental innovative medicines, and further, the United Kingdom has signaled that regulators would be eager and willing to accept real world evidence in support of regulatory submissions. Thats quite an interesting new pathway, because it also involves other stakeholders who are crucial for having effective market access, which are the payers and other entities we have in the United Kingdom who assess the cost-effectiveness of a product, Manley said.

The "Rolling Review"

Another feature of Britains now-independent medicines approval process is the rolling review that UK regulators employed to do a controversially rapid assessment of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) in 2020. UK countries became the first in the world to begin vaccinations with Comirnaty, and in defense of the rapid approval process, UK regulators insisted that it never got ahead of the availability of confirmatory data.

Rolling review is meant to reduce the risk of failure at the final stage and to ensure that the application is moving as fast as possible and addressing any potential issue that the regulators may have, Manley said. This review is available for any new active substance, including biosimilars and other biologics.

Also defining the UK system of approvals is the Accelerated Access Collaborative (ACC), which is a multistakeholder partnership (patients, industry, payers, regulators) to speed up patient access to innovative new treatments. This was established prior to Brexit, but the ACC is now the umbrella organization for support of UK health innovation, particularly focusing on medicinal products, including biologics and biosimilars, Manley said.

Although challenging for the United Kingdom, separating its medical products regulation from the European Unions has engendered optimism that systems are in place to spur investment and enable Britain to retain the position of one of the best life sciences platforms in the world, and this involved the United Kingdom listening to what the industry was saying about its difficulties, Manley said.

Theyve been extremely good in realizing that if the market of the European Union was going to be challenging, the rest of the world was available. Were looking toward being more global, trying to avoid duplication, reducing the time for procedures, and making it very attractive to the industry. We also have a pool of technologywhether genomics, artificial intelligence, or first class scientistswhich is there to stimulate this innovation. And obviously, if were successful with this, there would be more drug development investment in the United Kingdom.

A key development that sets the United Kingdom apart from the European Union is the way Britain has responded to an EU stance that the market for medicine is not sufficiently competitive and doesnt fully address the needs of patients for access and affordability. In Europe, fears are rising that pricing and other data disclosure requirements will be broadened and intellectual property rights diminished. The United Kingdom via the trade and cooperation agreement (TCA) established for Brexit has styled itself as a haven from these potential changes.

There is concern by the industry that the market exclusivities for orphan drugs and pediatrics medicines which are currently in place may change and may be reduced by the European Commission in the years to come, while the United Kingdom has made sure, in the negotiation of the TCA, that companies get the possibility to depart from Europe, in the sense that they keep a very high level of protection of those rights, Manley said. The United Kingdom has also confirmed that they want to protect the confidential nature of commercial pricing discussions with companies.

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The Brexit Rollout From the Biosimilars Perspective - The Center for Biosimilars