Get Ready: The Biosimilars Are Here

Recent developments mean that biosimilars are finally hitting the US market.


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 results of a survey show that although the majority of specialty physicians surveyed have heard about biosimilars, there are notable gaps in their knowledge about biosimilar concepts. The survey, designed by the Biosimilars Forum and conducted by SERMO, found five major gaps in the knowledge of 1,201 US physicians across specialties that are high prescribers of biologics. While more than three-quarters (76.8 percent) of physicians had heard the term biosimilars in the month prior to the survey, knowledge gaps included:

• Defining biologics, biosimilars, and biosimilarity
• Understanding the approval process and the FDA’s use of totality of evidence to evaluate biosimilars
• Appreciation that the safety profile of a biosimilar is expected to be the same as that of the originator biologic
• Understanding how decisions are made by the FDA for extrapolation of indications
• Defining interchangeability and the related rules regarding pharmacy-level substitution.

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.”


FDA is taking action to support market competition and potentially reduce drug costs by encouraging drug manufacturers to develop generic alternatives to off-patent drugs. The agency last month published a list of off-patent, off-exclusivity branded drugs that currently lack an approved generic equivalent. The agency also is implementing a new policy aimed at expediting the review of generic drug applications when competition is limited.

The newly implemented policy allows FDA to expedite the review of generic drug applications until there are three approved generics for a given drug product. The agency says it is revising the policy based on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available.

In July, FDA is hosting a public meeting to solicit input on places where the FDA’s rules—including the standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access.

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”


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About Practical Dermatology

Practical Dermatology is the monthly publication that provides coverage of medical care, cosmetic advancements, and practice management for clinicians in the field. With straight-forward, how-to advice from experts in various fields, we strive to enhance quality of care and improve the daily operation of dermatology practices.