Biosimilars Education: Oncobiologics/Premier Deal Aims To Boost Adoption, Data Collection
This article was originally published in The Pink Sheet Daily
Executive Summary
With two biosimilars set to move into Phase III this year, Oncobiologics hopes partnership with hospital services firm Premier will generate 'best practices around the optimal use of these cost-effective treatments.'
Oncobiologics Inc. is going to be working with Premier Inc. to educate doctors and the public about biosimilars, as it moves copies of blockbuster biologics Humira and Avastin into Phase III.
Based in Cranbury, NJ, Oncobiologics is part of an emerging class of biosimilar pure-play companies staking claim in a business dominated by big pharma, big biotech and big generics companies (Also see "Biosimilar Pathway Quickly Becoming Crowded In U.S." - Pink Sheet, 12 Jun, 2015.).
The company filed for an IPO this year [See Deal].
Two of its candidates are set to enter Phase III in 2016 – NS-3010, a copy of AbbVie Inc.’s inflammatory disease drug Humira (adalimumab), and ONS-1045, a biosimilar of Roche’s cancer drug Avastin (bevacizumab). The company has six other biosimilars in its pipeline, including a version of Roche’s Herceptin (trastuzumab), and says that its proprietary BioSymphony development platform is capable of generating two INDs per year.
Premier is a health care analytics and supply chain services company that has an alliance of 3,600 hospitals and 120,000 other providers in the US. Among other things, the company advises members on how to improve outcomes and efficiency in health care.
The firms announced on March 3 a deal to “accelerate the industry’s understanding of high-quality, cost-efficient biosimilars and advance the adoption of these complex drugs.”
Terms for the collaboration, which had been finalized in the past few days, were not disclosed.
The partners “will also work closely to inform providers, prescribers and the public sector on complexities involved in bringing biosimilar drugs to market,” Premier said in a statement. As part of its goal toward paving the way for adoption and prescriptions, they will create “best practices around the optimal use of these cost-effective treatments.”
The deal also involves provision to Oncobiologics of quality and cost control information, as well as market data, for the 3,600 hospitals in Premier’s network.
Premier noted the high cost of biologic and specialty drugs, which is expected to account for 50% of US drug expenses in 2018.
Hopes Are High; Awareness Isn't
Hopes are high for biosimilars at a time of intense scrutiny and concern about branded pharmaceutical pricing, but the market is still in very early stages and acceptance and trust among physicians still needs to be established for copy products to succeed commercially (Also see "Biosimilars: Improving Patient Access To Biologics While Bending The Cost Curve" - In Vivo, 8 Jun, 2015.).
Currently, the only biosimilar available in the US is Sandoz Inc.’s Zarxio, a copy of Amgen Inc.’s Neupogen (filgrastim), which was approved in March 2015 (Also see "Sandoz Biosimilar Approval Answers Questions On Labeling But Not Naming" - Pink Sheet, 9 Mar, 2015.). FDA’s Arthritis Advisory Committee recently voted in favor of approval of Celltrion Inc.’s Inflectra (CT-P13), a biosimilar of Johnson & Johnson’s Remicade (infliximab). The product is partnered with Pfizer Inc., following the big pharma’s acquisition of Hospira Inc.
The Remicade biosimilar has been sold under the brand name Remsima in some European countries since 2013, and to make the launch work, the commercial strategy involved a heavy dose of biosimilars education for physicians, pharmacists and payers (Also see "Lessons From The First Biosimilar MAb Launch In Europe" - In Vivo, 20 Oct, 2014.).
In a development that industry believes could help spur adoption, FDA now offers a continuing medical education course on biosimilars that includes instruction on legal aspects related to the products, basic definitions of what biosimilar products and the agency’s views on development and approvals.
According to the law, biosimiliar products must be "highly similar" to a reference product with no clinically meaningful differences, but clinical studies are not required for every indication. Rather efficacy can be extrapolated to multiple indications.
Even as FDA works to boost awareness of the products and the pathway, stakeholders note the responsibility for educating the public and health care community lies with industry – not government (A#14160223006]).
Execs commented on the need to educate physicians about biosimilars at Informa’s Pharmaceutical Strategy Conference in September 2015 (Also see "Biosimilars Education Needs To Come From Industry, Not FDA, NACDS Says" - Pink Sheet, 23 Feb, 2016.).
Pfizer’s VP Commercial Development Sophie Opdyke said at the meeting that to reach physicians, companies may need to supplement information submitted for regulatory approval with real-world data at the time of launch or after the launch.
Other execs acknowledged physicians' preferences for clinical data, and that the lack of this information for products approved through the biosimilars pathway creates a perception about safety risks. Consequently, there is a need for education about the value and sensitivity of analytical and biological tests.
Performance-based contracts for products approved through the 351(k) regulatory pathway could also help reassure physicians about biosimilars, according to Jonathan Dunn, an independent pharmaceutical pricing and market access executive.
Speaking at the World Congress Biosimilars Market Access Summit in February, Dunn suggested that an outcomes-based contract could link a biosimilar's net price to achievement of efficacy results or adverse event rates that are similar to that of the reference products (Also see "Biosimilar Uptake Could Be Driven By Outcomes-Based Contracts" - Pink Sheet, 29 Feb, 2016.).