Get Ready: The Biosimilars Are Here

Marking 10 years of clinical experience using biosimilars, the European Medicines Agency (EMA) and the European Commission in May published an information guide for healthcare professionals on biosimilar medicines. The guide, developed in collaboration with EU scientific experts in response to requests from healthcare professionals, was launched at a Stakeholder workshop on biosimilar medicines. The workshop—the third of its kind hosted by the European Commission—included patients, doctors, pharmacists, academics, and industry who shared experiences with biosimilar medicines across Europe.

The EU approved the first biosimilar in 2006. To date, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 28 biosimilars for use in the EU.

The non-profit Biosimilars Forum welcomed the EU publication, noting that it can serve as a guide for the US, which has been inching its way toward seeing biosimilars on the market.

“The report is a great guide for what the US needs to do,” observes Juliana Reed, Immediate Past President, the Biosimilars Forum. “The US probably is really 10 years behind Europe.”

The FDA only relatively recently approved a pathway for approval of biosimilars, and it cleared the first biosimilar for use—Sandoz’s Zarxio (filgrastim-sndz)—in March 2015. All the while, biosimilars developers and marketers, prescribers, and patients, have been eyeing the EU experience.

Lessons Learned

The European Experience demonstrates the benefits of advocacy and education, says Michael Werner, Policy Advisor at the Biosimilars Forum. With a bigger US market relative to Europe’s comes a bigger opportunity, Mr. Werner says. However, prescribers and patients must understand what biosimilars are and their potential role in patient care.

All in all, the EU experience has shown biosimilars to be generally safe and effective and typically comparable to originators. “Biosimilar trials are much shorter compared to the originator drugs, so we have less data overall as to their efficacy and safety. But what we do have says they are comparable,” says dermatologist Jashin Wu, MD, Co-chair of the International Psoriasis Council (IPC) Biosimilar working group. “Europe has more information over serveral years, and it seems that they have comparable efficacy and safety as the originators,” he adds.

“Some studies funded by originators found that patients who are doing well on reference drugs and are forced to switch to biosimilars experience more health care utilization,” Dr. Wu notes. “Presumably this is due to some loss of efficacy or side effects so they go back to see the doctor.”

US regulators have adopted approval pathways that, while not precisely modeled on those in the EU, are generally equivalent to those used in Europe. “The standards are not different,” Ms. Reed says.

The Supreme Court Weighs In

The Patient Protection and Affordable Care Act stipulated that the FDA would create a pathway for approval of biosimilar drugs, leading to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). FDA has, in turn, published several draft and final guidances relating to labeling, naming, and demonstrating interchangeability with a reference drug.

“There are no more regulatory considerations,” Dr. Wu says. “We are just waiting for the patent wars to be over. These drugs are approved, but it’s just a matter of when the issues surrounding patents will be resolved.”

Patent issues may be slowly resolving. The US Supreme Court last month ruled unanimously in favor of Sandoz, confirming that biosimilar companies do not need to wait for FDA approval in order to provide 180 days’ notice to reference product manufacturers of their intention to launch a product and clarified the process by which biosimilar manufacturers may provide confidential and proprietary information to reference product manufacturers in the patent exchange process. The Court confirmed Sandoz’ position that there is no federal remedy to force a biosimilar applicant to share proprietary information with reference patent holders. The Court ruled that reference patent holders may sue for access to information.

The ruling overruled a Federal Circuit Court of Appeals decision that biosimilar manufacturers must wait until six months after FDA approval to begin selling their biosimilar medicines due to the operation of the notice of commercial marketing provision of the statute. The Federal Circuit’s decision effectively created 12 and a half years of market exclusivity for reference product manufacturers.

The Supreme Court decision, “Solidified the legal and regulatory framework for biosimilars to take hold,” Mr. Werner says. “It reduced confusion …and provided some clarity about that aspect of getting to the market.”

With clearer understanding of the marketplace, “The market place can start to flourish,” Mr. Werner predicts. “Every business does better when they know what the rules are.”

The Question of Costs

“Cost reduction is the main purpose for having biosimilars,” observes Dr. Wu. According to one analysis cited in a Sandoz press release, estimates suggest that biosimilars could deliver up to $44 billion in savings to the US healthcare system by 2024. Pharmacy benefits manager Express Scripts estimates that the US likely wasted more than $45 million for every month that the Sandoz biosimilar Zarxio was delayed from coming to market.

“Some say we will see a 15 percent decrease in costs of biosimilar drugs, such as Pfizer’s Inflectra, versus originators such as Janssen’s Remicade (infliximab),” Dr. Wu says. “In some European countries like Norway, the cost of biosimilars is 70 percent lower than the originators.”