As approvals roll in, barriers to biosimilars, competition remain


In its 2016 report on generics savings for the Generic Pharmaceutical Assocation, Quintiles IMS included a snapshot on one of the quickly burgeoning fields of more affordable medicine, biosimilars. Currently, biosimilars are expected to save the healthcare system between $44 billion and $250 billion in the next 10 years.

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Since the entry of Zarxio, a biosimilar of Neupogen, four biologics have been approved in the United States: Sandoz’s Enbrel biosimilar, Erelzi; Boehringer Ingelheim and Eli Lilly & Co.’s Basalgar, an insulin glargine follow-on biologic to Sanofi’s Lantus; Amgen’s Amjevita, a biosimilar of Humira and the first monoclonal antibody biosimilar; and Pfizer and Celltrion’s Remicade biosimilar Inflectra, which is planned to launch in late November despite Remicade maker Janssen’s court filing calling for an injunction against the launch.

With 50 biosimilars in development, biosimilars could be poised for a boom in the coming years, but some barriers still remain. At an Oct. 27 conference, John Jenkins, the FDA Center for Drug Evaluation and Research’s Office of New Drugs director, told attendees that many manufacturers aren’t clear on what the FDA looks for when evaluating a biosimilar — namely, biosimilarity to the reference product, rather than the safety and effectiveness on which the reference product is evaluated. This, he said marks a shift in thinking around biologics for everyone.

“It requires a cultural and cognitive transformation,” Jenkins said. “Significant progress on this shift has been made within the FDA, but it is still a work in progress for some applicants, as well as for many clinicians, patients and other stakeholders.”

Beyond changing how companies think about the way their product is being evaluated, other barriers remain to biosmilars’s widespread use, as well as a level of competition that could drive price reductions beyond the general 10% to 15% that biosimilars currently offer. One of the largest barriers to competition identified by Numerof & Associates research analyst Michael Kuchenreuther is interchangeability.

Though such countries as Germany, where biosimilar use is widespread, urge providers to prescribe biosimilars whenever possible, in the United States, biologics and their biosimilars are not always interchangeable in the way that most generics are, and with monoclonal antibody biosimilars entering the market, this will provide a challenge for manufacturers hoping for rapid adoption and payers looking to cut costs.

“Issues of interchangeability aren’t as prevalent with [biosimilars like] Zarxio because those drugs are typically administered more acutely, it’s not a chronic treatment administered over a long period of time,” Kuchenreuther told Drug Store News. “Until there’s clarity on what it takes to have that interchangeable status — and along those lines, the FDA still hasn’t released true guidance in that area and aren’t expected to do so until the end of next year — … interchangeability will be a major determinant of a biosimilar’s potential and the ability for payers and providers to use these drugs as a source of competition.”

Biosimilars also face the challenge of competing with the makers of their reference product, which due to the size of their markets — as of May 2016, according to IMS Health, Humira had moving annual sales of $11.4 billion, Enbrel $7 billion and Remicade $5.1 billion — Kuchenreuther said biologies manufacturers are working to add value to their products whose share could soon be challenged by biosimilars.

“They’re looking to create more value-added services — things to wrap around their product so they’re not just a provider of a good, but rather a provider of an overall solution for healthcare providers, for consumers who are increasingly having to put more skin in the game,” he said. “They’re making it harder for people coming later into the game to become equivalent. Biosimilars not only need to be similar from a bioequivalency and pharmacokinetic aspect, but they also need to be market similar.”

If biosimilars don’t provide the same value, because “if they’re not then the 10% to 15% premium on the biologic over the biosimilar could very well be justified,” Kuchenreuther said.

All the difficulties aside, Kuchenreuther said he sees the landscape changing to accommodate biosimilars in the coming years, but there are challenges ahead.

“There’s a lot of things we need to continue to do to make that market more hospitable,” he said. “It’s about finding that proper balance between preserving more intellectual property and incentives for innovation, while also making it even easier and more accelerated for bringing more of these biosimilars to market.”

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