Amgen Calls For Balance To Support Biosimilars

In the world of small-molecule generics, firms that move from developing off-patent medicines towards focusing on innovative drugs are sometimes described as “poacher turned gamekeeper,” reflecting the change in mindset that comes when moving from a position of targeting brands to defending them.

In the biologics arena, however, Amgen has done the opposite, with the originator branching out into the world of biosimilars and building up a major business in off-patent biologics that complements its innovative interests.

As such, the firm can offer a “unique perspective” on biosimilars thanks to its dual status as a major player in both biosimilars and innovative biologics, the company’s executive director of marketing and global biosimilars commercial lead, Chad Pettit, has told Generics Bulletin in the first part of an exclusive two-part interview.

At the same time, he has also called for policies that support competition among biologics and biosimilars; science-based education to keep stakeholders informed, including in new treatment areas; and strong and predictable incentives for innovation through intellectual property protections for novel biologics.

Talking to Generics Bulletin shortly after Amgen published a preview of its 2022 Trends In Biosimilars report (see sidebar), Pettit set out Amgen’s status as a leader in both innovative biologics and biosimilars. 

“Amgen has more than 40 years of experience, with a proven track record of delivering high quality, safe and effective medicines with a reliable supply,” Pettit highlighted. “We have leveraged this expertise to deliver a differentiated and industry-leading biosimilars portfolio.”

Suggesting that this gave Amgen a “unique perspective, with a legacy in innovation and one of the largest stakes in biosimilars among our industry peers,” Pettit observed that the firm had so far “invested over $2bn across a portfolio of 11 biosimilar medicines, focusing primarily on oncology, hematology and chronic inflammatory diseases,” with five biosimilars so far approved in the US and four commercially available. (Also see "Amgen Provides Ambitious Update On Biosimilars Business" - Generics Bulletin, 17 Jan, 2022.)

Asked about the current state of the US biosimilars market, Pettit described the present era as a “pivotal time for biosimilars in the US.”

“Biosimilars are now well-established and growing across multiple therapeutic areas,” he outlined, with nearly 40 biosimilars approved by the US Food and Drug Administration and over 20 different products launched “across multiple classes, providing patients, physicians and payers with a range of treatment options and a greater degree of flexibility of choice.”

And even in the face of constraints resulting at least partially from COVID-19 restrictions over the past couple of years – leading to a slowdown in approvals and delays to FDA inspections (Also see "US Biosimilars Enjoy A Year Of Firsts In 2021" - Generics Bulletin, 31 Dec, 2021.) – data suggested that the market was still healthy, Pettit pointed out.

“Although there was an overall decline in the number of approvals during the 2020 to 2021 timeframe,” he acknowledged, “the number of development programs that are participating in FDA’s Biosimilar Development Program has continued to rise, with 96 biosimilar development programs enrolled, to date.”

And looking ahead, Pettit suggested, “the US is poised to see continued growth in biosimilar approvals, similar to pre-pandemic rates, spurring additional competition that will potentially lead to significant savings for the healthcare system, which can then be deployed to newer, innovative treatments.”

Policymakers Must Maintain ‘Right Balance’ For Competition

Asked what were the major obstacles in the market for biosimilar sponsors – and what regulatory or legislative solutions could help to improve the landscape for biosimilars – Pettit was positive about existing conditions while acknowledging the importance of creating a policy environment that supported competition.

“We believe that the current regulatory pathway in the US for biosimilars is both rigorous and science-based, which is vital for stakeholder confidence,” he explained. And in terms of supporting the market, “policymakers can best nurture a long-term, sustainable marketplace with biosimilars by maintaining effective policies that allow head-to-head competition between reference products and biosimilars and among biosimilars.”

“If the right balance is maintained,” Pettit suggested, “biosimilar competition will continue to produce meaningful savings that will endure well into the future.”

“Promoting science-based education about biosimilars and awareness of current regulatory standards will reduce uncertainty regarding the biosimilars marketplace.”

On the subject of misinformation around biosimilars and how industry stakeholders can help to counter this, he reaffirmed that the “long-term viability of the industry depends on a competitive marketplace in which patients, providers and payers have a real understanding of and confidence in biological products, including biosimilars.”

“As part of Amgen’s investment in biosimilars, we are committed to staying at the forefront of biosimilar education,” he pointed out, suggesting that “promoting science-based education about biosimilars and awareness of current regulatory standards will reduce uncertainty regarding the biosimilars marketplace, promote uptake and support the continued development of both reference products and biosimilars.”

“Amgen has made it a priority to coordinate with regulatory agencies, patient and professional advocacy groups and medical societies in efforts to promote the advancement of science-based educational initiatives and policies on biosimilars,” Pettit underlined.

As part of this, he added, the company hoped that its Trends In Biosimilars report “may also help patients, providers, payers, policymakers and other audiences better understand the critical role biosimilars play in promoting a resilient US healthcare system and how stakeholders can prepare for, and help drive, rapid expansion of the US marketplace with biosimilars.”

IP Protections ‘A Vital Component Of A Successful Marketplace’

Given Amgen’s status as both a biologic innovator and a biosimilars developer, Pettit was asked about Amgen’s view on the IP environment for biologics, especially in light of ongoing controversy over so-called “patent thickets” restricting generic and biosimilar market entry. (Also see "US Senators Urge PTO’s Vidal To Tackle Pharma Patent Thickets" - Generics Bulletin, 27 Jun, 2022.)

“A foundation of intellectual property is a vital component of a successful marketplace,” he summarized, explaining that IP was “essential to promoting research and development that delivers cutting-edge medicines and addresses unmet medical needs.”

“Affordability and sustainability should be balanced with practical solutions that safeguard incentives for innovation,” he argued. “Providing strong and predictable incentives for innovation will lead to the next cutting-edge product, which in turn can lead to a biosimilar of that product and promote competition.”

“Without these IP protections,” Pettit elaborated, “not only does the originator pipeline dry up, but the biosimilar pipeline does as well.”

Ultimately, he concluded, “a strong IP environment promotes competition among originator products, biosimilars, and generics – supporting continued choice for patients and prescribers.”

“Transparent, uniform, and predictable legal and administrative processes for securing IP rights establish a foundation for a marketplace where both innovation and competition can thrive.”

‘More Work To Be Done’ To Drive Uptake

With the latest Amgen report showing steep uptake curves for recently-launched US biosimilars such as trastuzumab, bevacizumab and rituximab, Pettit was invited to comment on key factors influencing uptake, especially as biosimilars become available in new therapeutic categories.

“Biosimilar medicines are accepted by many physicians, but some uncertainty and lack of comfort regarding the regulatory pathway and efficacy remains,” he acknowledged, “not only for those in cancer centers, but for all healthcare facilities. It’s clear that continuing education on biosimilars is necessary to increase physician understanding and prescribing of biosimilars.”

However, he pointed out, “physician awareness of biosimilars has continued to grow.” Citing a recent Cardinal Health report, Pettit noted that “55% of oncology prescribers, 53% rheumatology prescribers and 40% of ophthalmology prescribers described themselves as “very familiar” with biosimilars.” (Also see "US Has Opportunity To Lead On Ophthalmic Biosimilars" - Generics Bulletin, 24 Feb, 2022.)

“But there’s still more work to be done to advance understanding and trust in this important and emerging class of medicines among prescribers,” he conceded.

Moving forward, he suggested, health systems and providers would need to prepare for the growing availability of biosimilars by anticipating potential differences in delivery device between a reference product and a biosimilar; understanding differences in electronic health record tracking when stocking the reference product and biosimilar; and becoming familiar with major payers’ coverage and reimbursement policies for biosimilars.

“From Amgen’s perspective, each therapeutic category is unique,” Pettit outlined. “So, given the differences noted, success will be measured differently – taking into consideration physician and patient familiarity, the number of products available and length of availability, and the complexity of the disease state.”

“We believe the interchangeable designation has value for biosimilars dispensed at the pharmacy, and while we are investing in it, we also recognize that there are other critical factors for biosimilar medicines to succeed in the marketplace.”

Moving on to discuss interchangeability – with multiple biosimilars now approved as interchangeable by the FDA and two interchangeable rivals to Humira (adalimumab) potentially launching next year (Also see "Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown" - Generics Bulletin, 9 Mar, 2022.) – Pettit highlighted that the mechanism’s facilitation of pharmacy substitution for biosimilars “can ultimately streamline administration for pharmacists and patients in some cases.”

“We believe the interchangeable designation has value for biosimilars dispensed at the pharmacy,” he indicated – but “while we are investing in it, we also recognize that there are other critical factors for biosimilar medicines to succeed in the marketplace.”

“Interchangeability can be a relevant and important attribute for a biosimilar, but it is not a necessity when bringing a new biosimilar product to market,” he suggested. “We look at all of the attributes – interchangeability being one of them – that matter to patients, payers and providers such as affordability, patient experience, device and reliable supply.”

Again pointing to the recent Cardinal Health report, he added that “provider perceptions of biosimilars have evolved from a 22% acceptance of interchangeability in 2017 to a near 100% for some indications in 2021.”

In the second part of this interview, Pettit discusses upcoming prospects for biosimilars as Amgen prepares to launch the first US Humira rival, as well as the firm’s longer-term aspirations for its biosimilars business.  (Also see "Frontrunner Amgen Expects US Biosimilars To ‘Shift Significantly’ With Adalimumab" - Generics Bulletin, 13 Jul, 2022.)