An update on SEBs

June 24, 2016

Since we first covered subsequent-entry biologic drugs (SEBs), or biosimilars, in our fall 2014 issue of Follow the Script, this hot topic has gotten even hotter. Back then SEBs were just coming on to our radar, and even now Health Canada has approved only three SEBs. But as a number of blockbuster biologic drug patents have expired or are set to expire over the next several years, we expect many more SEBs to come on the market.

To get a new perspective on the role of SEBs, we reached out to Pfizer Canada and had an interesting talk with Gerry Stefanatos, general manager, Global Established Pharma Business, and Vincent Lamoureux, director, Corporate Affairs. With significant experience and expertise in biologics, Pfizer has made a big commitment to the development of SEBs, which it sees as a logical and necessary step to be relevant in the emerging pharmaceuticals landscape. To that end, Pfizer has 14 SEB products either under development or launched someplace in the world.

Let’s review...

Before we go any further, let’s review our introduction to SEBs from the fall 2014 issue of Follow the Script: An SEB is a biologic product that is similar to an approved originator (or innovator) biologic product. To be approved by Health Canada, an SEB application follows the New Drug Submission process and must demonstrate the same clinical outcomes in terms of safety and effectiveness as the originator product. For example, Gerry confirms that the approved indications for Hospira’s Inflectra were granted on the basis of similarity between Inflectra and the reference product, Remicade.

Are SEBs generics?

SEBs often get compared to generic drugs, but they differ in two important ways. First, they are not identical copies of the original products and therefore not interchangeable by pharmacists. Second, unlike generics, SEBs are required to undergo a more complex regulatory approval process that includes original studies demonstrating safety and effectiveness.

As Gerry explains, the regulatory process that SEBs undergo is evidence based and very rigorous. “Data required by Health Canada to support market authorization of SEBs includes quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology), and clinical (pharmacology, safety, and efficacy) information. Demonstration of similarity to the reference biologic drug is required by Health Canada.”

As well, the manufacturing of SEBs involves a more complex process than for traditional generic drugs. As a result, SEBs are typically not able to achieve the same price points as generic drugs – the current SEBs approved in Canada are priced 15 to 47 per cent less than originator products whereas generics can be up to 78 per cent less than the brand-name products. However, because biologic drugs are extremely expensive to begin with, the actual dollar savings achieved through the use of SEBs are substantial.

Facing challenges

While SEBs are fairly new in North America, they have been available in Europe for over a decade, where they have been established as safe and effective and are steadily gaining market share in many EU countries. We can learn from the European experience as Canada and the rest of North America face some key challenges to rapidly creating a viable and sustainable market for SEBs, such as:

  • Physicians are hesitant to prescribe SEBs as they may not be aware of what SEBs are available or that they offer viable treatment options.
  • Patients may be resistant to trying an SEB when they don’t understand what SEBs are or that they are as safe and effective as originator products.
  • Slow movement by payors to support the SEB industry – at both the provincial plan and private carrier levels despite SEBs offering significant savings to the system.

Overcoming these challenges seems to call for more education, better marketing, additional patient support, and competitive pricing. As more SEBs go through Health Canada’s regulatory process, the acceptance of SEBs as an alternative option will undoubtedly increase.

Gerry comments that “CADTH’s [Canadian Agency for Drugs and Technologies in Health] additional layer of review provides an added comfort level but it slows down adoption of SEBs in the market. It can be well over two years from the time a NOC [Notice of Compliance] is issued by Health Canada and the provincial reimbursement of the drug. We would like to see evidence-based adoption mechanisms to create a sustainable marketplace for SEBs and get them on the market faster which would lead to greater savings for patients and payors.”

Can SEBs be substituted for an originator product?

While a generic drug is an exact copy of a brand-name drug, the same is not true of an SEB and its originator drug. Due to the complex nature of the manufacturing process, they are similar, but not identical; therefore, Health Canada does not consider SEBs and originator products interchangeable. This means that pharmacists THREE cannot automatically substitute the SEB for the originator biologic – a physician must specifically prescribe the SEB. However, if the originator product is prescribed, the pharmacist can get authorization from the physician to dispense the SEB instead.

Research in Europe, and elsewhere, is underway to study the effects of switching patients from certain originator products to an SEB. All early evidence points to switching being a viable strategy that preserves patient safety while generating the cost savings needed to ensure the sustainability of drug plans. However, further research is needed to conclusively demonstrate the feasibility of switching patients to SEBs. In the meantime, encouraging physicians to prescribe an SEB as the first choice would go a long way to increasing the uptake of these drugs in Canada.

Gerry brings up the interesting point that there are different prescribing mechanisms at play in Europe than we find in Canada. “In Europe, SEBs are mainly used in a hospital context rather than being a prescribing decision made in a Canadian physician’s office. Not having to educate physicians one-by-one is a huge accelerator in the adoption of SEBs.”

GSC’s SEB policy

GSC’s recently publicized policy lists SEBs as preferred products under our formularies. Current users of the originator biologics are grandfathered under the policy. With SEBs costing much less than the originator product, our approach ensures that plan members starting on a new therapy, who can safely and appropriately use an SEB, will be required to do so to receive reimbursement.

Our SEB policy is designed to be flexible and accommodate the rare circumstances when an SEB may not be appropriate for a plan member. For example, in the case of Remicade, some patients may require unique dosing that may not be available through the SEB. In these cases, we will approve the originator product to ensure the plan member can receive the appropriate treatment. In our current experience with SEBs, these situations tend to be extremely rare; for the vast majority of plan members, SEBs are an appropriate option.

With substantial cost savings on the table, we expect to see our approach implemented more widely by other carriers as more SEBs become available and Canadian physicians become more experienced in prescribing.

What’s next?

To conclude our meeting with Gerry and Vincent, we asked what the next wave of SEBs will yield. Gerry says that oncology drugs are very important in Pfizer’s line up and will be the next “big products” to come to the market. “The adoption of these drugs should be easier as they are generally hospital-based infusions and we expect an accelerated uptake process to be in place. By then, there will be more of a comfort level for SEBs as physicians and patients gain more experience with the concept.”