Isha Bangia, PharmD, MBA, is a manager of US market access at Certara Evidence & Access. She received her PharmD from Rutgers University and an MBA from Johns Hopkins University. Her current responsibilities include optimizing product value stories and working with customers to improve access across the US healthcare system. Her experience includes practicing pharmacy, payer market research, and pharma strategy and analytics. Her work has covered many therapeutic areas, including biosimilars, oncology, diabetes, vaccines, and rare diseases.
Amgen's Onpro autoinjector device for pegfilgrastim is a stunning example of how product differentiation via drug delivery devices can protect market share in the biologics market.
Product differentiation is a critical component of product strategy, especially for biologics and biosimilars, as drug competition across therapeutic categories continues to increase. For disease types with multiple competing brands of a single type of medicine, there are sometimes opportunities for manufacturers to demonstrate value beyond clinical parameters.
Drug delivery systems such as devices, technologies, and formulations—which may offer faster or slower medicine release—have become key value differentiators that manufacturers continue to invest in. The attractiveness of these devices may improve physician and patient acceptance, leading to improved revenues and market share; and the ease and convenience of devices may influence patient adherence and satisfaction. Further, patient comfort with a device may lead to brand loyalty, regardless of whether cheaper options (generics, biosimilars) are available.
Also important for manufacturers, delivery systems may serve as a patent protection strategy and thwart biosimilar competition. A prominent example of this is the success of Amgen’s Neulasta Onpro, a wearable pegfilgrastim injector kit that reduces the number of office visits patients need to make.
Amgen Launches Neulasta OnPro
In 2015, Amgen’s blockbuster Neulasta (pegfilgrastim), an oncology supportive care agent, lost exclusivity and became subject to biosimilar competition. Since then, 4 pegfilgrastim biosimilars have been approved in the United States—Fulphila (Mylan), Udenyca (Coherus), Ziextenzo (Sandoz), and Nyvepria (Pfizer)–of which 3 have launched. By 2019 these biosimilars had captured less than 25% of the pegfilgrastim market, but indications were that Neulasta would not be able to continue dominating this market.
In just the second quarter of 2020, Neulasta sales decreased 28% due to biosimilar competition. Despite this decline in sales for the originator product, Amgen has retained a sizeable share of the pegfilgrastim market due to the Neulasta Onpro, which the company launched in 2015.
As a delivery system, the Neulasta Onpro wearable injector enables patients to go home after chemotherapy and receive an automatic follow-up pegfilgrastim injection the next day. The convenience of this device, particularly for patients who have to travel many miles for chemotherapy treatment or could not easily schedule visits as the COVID-19 outbreak spread, has given Amgen a tremendous competitive advantage in the pegiflgrastim market. By midyear 2020, the Onpro held a 58% share of the pegfilgrastim market.
Amgen has focused on switching Neulasta patients to the Onpro kit as a part of its product life cycle extension strategy and defense against biosimilars. Consequently, Amgen has maintained a sizeable market share while limiting the uptake of biosimilars. There is no biosimilar delivery device comparable to the Neulasta Onpro, and pegfilgrastim biosimilars cannot be used with the Onpro. This means that, purely from the convenience aspect, physicians and patients may be discouraged from using a biosimilar pegfilgrastim, even if biosimilars are preferred from the payer side. Further, although Neulasta’s patent exclusivity ended in 2015, Neulasta Onpro is still patent protected.
Interestingly, the original Neupogen product was itself a product differentiation strategy. Whereas filgrastim (Neupogen, Amgen) must be injected daily for up to 2 weeks, Neulasta can be administered once every 3 weeks as a single, fixed dose during the patient’s chemotherapy cycle.
Outside of Neulasta Onpro, manufacturers have employed other delivery systems to extend product life and avoid biosimilar competition. In 2017 Amgen launched an auto-injector for etanercept (Enbrel Mini) that was designed to reduce the pain of patient-administered injections. Further, AbbVie, owner of the adalimumab reference brand (Humira), which stands to lose exclusivity in the United States in 2023 to multiple biosimilar competitors, has a longstanding partnership with Unilife to use a system that allows patients to synchronize auto-injector products with their smartphones.
On the formulation side, in an effort to stall sales erosion to biosimilars for the trastuzumab originator Herceptin, Roche/Genentech has developed a subcutaneous delivery system (Herceptin Hycleta), which was approved by the FDA in early 2019.
Lifecycle Management Strategies
Manufacturers have often used drug delivery systems to ward off competition following loss of exclusivity. With small molecular entities, this was seen with the introduction of extended or delayed-release products that would limit generic uptake. Now, such is the case with biologics. The number of drug-device combination patents, in general, has increased in recent years, marking the upward trend to differentiate and capture market share through delivery systems. Investigators reported that drug products with an associated patented delivery device rose from 3% in 2000 to 10% in 2016.
The number of strategic partnerships in the biologics space has increased as well, such as in the insulin and immunology categories, all of which demonstrates that developing and patenting convenient delivery systems (devices, formulations) that drive patient compliance and improve outcomes are embraced among manufacturers as advantageous life cycle management strategies against biosimilar competition.