Trust, Planning Key to a Successful Biosimilar Launch, Panelists Say

FDA approval of a biosimilar doesn’t mean a successful market launch. There are myriad obstacles to overcome, and the pharma companies that own reference products are not going to give up market share without a fight, said panelists Thursday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

Ultimately, developing trust in the biosimilar and working out a long-range, comprehensive, and multipronged strategy for sales channel penetration will work in favor of a marketing effort, they agreed.

They discussed strategies used to get biosimilars to market and tactics used by originator product manufacturers to hold the door closed to competition.

Biosimilar companies looking to chip away at market share can expect established manufacturers to be ready for them, said Peter Zurawski, managing partner at PharmaKonnect and vice president of Grand Marketing Solutions. Zurawski has consulted for originator companies on how to keep their products in front of the competition.

“Some of the originators have had biosimilar defense teams in place for 9 or 10 years already,” Zurawski said. “These larger manufacturers are not going to lay down. They’re not going to go away,” he said.

They have a playbook, and they don’t always need to rely on clinical data to convince doctors and patients that their originator products are superior. Force of habit on the part of doctors and consumers, plus steadily working to erode trust in biosimilar products, tends to work well for originator companies, he said.

“That’s a big piece. It’s understanding the prescriber and the patient, which goes beyond science. That’s psychology. There’s a lot of marketing, also,” Zurawski said.

“Take an analogy where you’re going down to the gas station to get a 99-cent coffee. That’s fine. It’s just coffee. But you drive down the street and you see Starbucks and there are 50 people waiting in line 20 minutes to get their coffee. There’s marketing there. Starbucks either has a better product or they’ve convinced people they have a better product than just the coffee that’s at the gas station,” he said.

Panelist Vanessa MacGregor, PharmD, director of specialty pharmacy at Sandoz, said she’d like to see biosimilars renamed to “biosame.” Sandoz recently lost a court battle with Amgen, which successfully contended that Sandoz’s biosimilar version of etanercept (Enbrel) infringed on multiple patents. Sandoz’s biosimilar, Erelzi, has therefore failed to launch on the US market.

Nevertheless, Sandoz boasts a robust biosimilar portfolio and pipeline in immunology, oncology, and endocrinology. These drugs include filgrastim-sndz (Zarzio), for boosting white blood cell count.

To prepare for a biosimilar launch, MacGregor said, it’s essential to coordinate brand experts and trade channel and market access specialists and do an extensive landscape assessment, leading to a timeline for launch of the biosimilar. “Ideally you want to be first and get most of the revenue,” she said.

A careful assessment should be made of the originator product, including how and when it was launched. “Was it open distribution, where the product was available in all channels, or was it via closed distribution, and do those things make sense for your biosimilar?” she asked.

"It’s imperative to decide whether to push the product through payer channels,” she added. Then, a vigorous alignment “throughout the franchise” is necessary to get the product flowing through managed care and specialty pharmacies.

Panelists and audience members tended to agree that the type of health network matters a great deal. “Hospitals and health systems have the ability to drive the conversion to a biosimilar and provide education for patients and clinicians, so it becomes a little simpler on the medical benefits side,” MacGregor said.

“The challenge on the pharmacy benefit side is there are no real closed systems where the pharmacy benefit is covered,” she said.

Academic systems tend to be more pioneering with biosimilars, agreed Scott A. Soefje, PharmD, RPh, director of pharmacy at Mayo Clinic, and Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare.

Physicians tend to be open to using whatever the academic institution wants, Soefje said. They just want to know the name of the drug they should be ordering, whether it’s a biosimilar or a brand. “That’s the response I receive every time,” Soefje said.

Zurawski said that in a less-contained setting, physicians may tend to prescribe based on convenience or pressure from the manufacturer. Providers may not be very price sensitive if their patients’ co-pays are fixed, he said.

Further, he described an instance where a generic had launched and the manufacturer soon noticed that sales of its originator product were dropping. A little investigation revealed that although doctors were prescribing the brand drug, pharmacists were making the switch to generic at the distribution point. The manufacturer told sales teams to tell their providers to start writing DAW, or dispense as written, on prescriptions, and sales quickly reverted in favor of the brand drug.

The panel also talked about acceptance of clinical information from markets abroad. Europe, for example, has a lot more experience with biosimilars and the real-world evidence is accumulating. But pound for pound, that clinical data is just not accepted as readily as a study done in the United States. In other words, it’s hard to make a case for US acceptance of a biosimilar based on data on the same drug collected in Europe.

“Sometimes the [foreign] studies show the same efficacy,” MacGregor said. “These data are not always widely accepted. We have the AbbVies, Amgens, and Janssens that have their own marketing that is not necessarily pro-biosimilar.”

However, good clinical data and a consistent message can help to develop trust in a biosimilar product can open doors to acceptance among providers and patients, panelists agreed.

The panel was moderated by Cate Lockhart, PharmD, PhD, executive director at Biologics and Biosimilars Collective Intelligence Consortium.