Will 2017 See a Biosimilar Bonanza in the US?

How biosimilars are overcoming the barriers to market access in the US



Cut-price biosimilars offer the potential of huge savings for cash-strapped healthcare systems across the world, yet getting them approved in the United States, the largest biologics market, has proved more difficult than many predicted.

However, with the global biologic medicines market expected to exceed $390bn by 2020, and many of the top-sellers facing loss of exclusivity, biosimilar companies and healthcare payers have plenty of incentives to overcome the legal, scientific and regulatory barrier to successful commercialization in the US.

2017 may see the regulatory fog start to lift, says Scott Foraker, Vice President and General Manager, Biosimilars, at Amgen. “There’s hope, but it’s complicated; as many as five biosimilars may be approved by the FDA this year but it remains to be seen if 2017 will see the re-emergence of the early applications that failed to pass muster.”

A big investment

There have been several critical roadblocks to the introduction of biosimilars, says Foraker. “Like others, we have found that it is much harder and more expensive to develop biosimilars than most people initially thought. Firstly, it’s a Herculean task to scientifically match more than a hundred different product attributes for these complex monoclonal antibody products – so the scientific challenge is high. Secondly, it takes a lot of investment; many people predicted that they could bring a product to market for $50-100 million but we are finding it’s more like $200 million or more.”

Ensuring the infrastructure exists to bring these products to market is another challenge, he says. “You need the scientific expertise in biologics to create that biosimilar molecule both on the manufacturing side and the commercial side. You also need infrastructure to educate stakeholders and get them into the hands of patients and physicians.”

With significant expertise in biologics, plus the infrastructure and investment, Amgen is well-placed to succeed, says Foraker. “The scientific challenges are right up our alley; as a biotechnology pioneer and leader, we have 35 years’ experience and the manufacturing expertise to tackle these challenges and that’s what we’re doing.”

The company is also bullish about its ability to navigate the choppy legal and regulatory waters. “Outside of Europe – where biosimilars have been on the market for five or more years – regulators have to come up with different ‘rules of the road’, plus the legal pathways are quite different. For small molecules, there’s typically a small number of patents but, with biologics, there are multiple layers – manufacturing process patents, method of use patents, etc. – which create unique issues.”

Delays have also been part and parcel of getting biosimilars onto the market, although a decision by the US Supreme Court to hear a landmark legal case between Amgen and Novartis’ biosimilars division, Sandoz may help streamline the approval process. Currently, biosimilar companies must wait six months after notifying the originator, which Sandoz argues creates a “exclusivity waterfall” for the originator. The outcome of the case will clarify the interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and impact the entire US biosimilars industry.

Overcoming uncertainty

Education is vital, says Foraker, not just in ensuring that healthcare professionals, patients, and payers understand the clinical benefits but that they also understand the broader benefits biosimilars can bring to the health system.

“The number one question in the mind of stakeholders is around what they’re giving up in the name of cost savings. Are they compromising on quality or patient services or reimbursement services? We believe we have an answer to that question; we’re bringing high-quality biosimilars made by the same scientists and in the same factories and drawing upon our biologics expertise. We also promise to supply them reliably unlike the small molecule generics industry, which has been plagued with product shortages,” he says.

Awareness is growing but more education is needed, particularly to pave the way for the introduction of complex monoclonal antibody oncology biosimilars, where there may be greater reluctance among stakeholders to switch from therapies known to be effective to the use of biosimilars, says Foraker’s colleague, Chad Pettit, Executive Director, Global Value and Access, Biosimilars, at Amgen.

“When I talk with stakeholders, their understanding is limited, even in Europe,” he says. “With oncology therapeutics – where the opportunity for cost savings is enormous given the many combination therapies and the more than $20bn of products soon to come off patent – there’s a lot of room for education. Such education is for patients, in terms of when it’s appropriate to switch or use biosimilars, and for payers, in ensuring that decisions about payer formularies and reimbursement are made in balanced way.”

Demand will drive success, says Foraker. “For biosimilars to be truly successful, we must create confidence in their use. I don’t think forced actions by governments or payers will make biosimilars successful; they will only gain traction if there is demand for them and people want to use them. It comes down to education and that’s a challenge for the entire industry.”

The safety of switching lies at the heart of the entire debate. “Regulatory authorities require one switch to be done in a biosimilar study, so part of the regulatory approval process is a clear sign that it’s safe to switch from the reference product to the biosimilar,” says Foraker. “However, how safe is it to switch from one biosimilar to another? We don’t know the answer to that question; there’s no data. Given this uncertainty, our advice is to choose once and choose carefully.”

Key Questions Yet to Be Answered in the Evolving Biosimilars Market

• Timing of market entry
• Number of competitors
• Discounts offered by biosimilar competitors & originators
• Potential delays caused by patent disputes
• Policies that continue to shape the biosimilars environment (reimbursement, labelling, naming, interchangeability and state pharmacy laws)

 


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