By Anna Rose Welch, Chief Editor, Biosimilar Development
In the weeks preceding the holidays, the Biosimilar Development editorial board and friends were featured in two separate articles, one pinpointing the progress made — or not made — in 2019, and what questions they have for the upcoming year. Now, in part three of this four-part series, the experts are back to point us toward the big events of the forthcoming year they expect will advance the industry. Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry. Check out their wide variety of observations, questions, and expectations below!
What is one big market development you anticipate we could see in 2020 that will advance the industry? (This could be a new policy, product launch, regulatory decision, etc.)
Insulin is getting a lot of attention with the upcoming March 23, 2020 transition of insulin, among other molecules, to the regulatory framework for biologic products. As of that date, abbreviated biologics applications for biosimilar insulin products will be accepted by FDA with reference to previously approved insulin products. This will open those reference insulin products to the type of competition the BPCIA was designed to foster, and hopefully lower costs and increase access in the long-run. To further that aim, FDA recently released guidance for the industry that is intended to aid manufacturers in developing and preparing applications to market biosimilar insulin products. Interestingly, the draft guidance states that a comparative clinical immunogenicity study may not be necessary for all proposed insulin biosimilars, which could lower development costs and shorten approval timelines.
- Alexandra Valenti, Partner, Goodwin Procter LLP
I anticipate we could see movement towards greater international regulatory collaboration and convergence to improve efficiency and reduce duplication in requirements. This topic has received increasing traction over the last few years, and there seems to be growing willingness to cooperate in support of true global biosimilar development. I am optimistic that we can progress on this topic in 2020.
- Erika Satterwhite, Head of Global Biosimilars Policy, Mylan
Celltrion anticipates seeing an initiation of market development in terms of personalized or tailored treatment in 2020.
We anticipate there will be cost competitiveness when accompanied by better efficiency and improved clinical features and outcomes. There will also be advancement on monitoring kits by reducing the lead time (i.e. Point of Care (POC) testing).
- HoUng Kim, Head of The Medical and Marketing Division, Celltrion Healthcare
There will be new biosimilar launches, and existing biosimilars taking more market share from the reference product, resulting in increased market competition, particularly in oncology. Competition is going to be very dynamic in certain diseases, and as a result we should see significant reductions in market share of the reference products. More biosimilar usage in certain indications is taking off and will continue to do so. The Canadian payer experience requiring the switch to biosimilar infliximab (as a start) will be interesting to watch as the reference product manufacturer tries to defend its territory by sending letters to patients encouraging them not to switch. Of course, there is always the exceptional patient where it may not be wise to switch for medical reasons, but that is the doctor’s decision and does not occur in a majority of cases. Will this ever happen in the U.S.?
- Sue Naeyaert, Consultant, Former Global Government Affairs, Policy, and Pharmacoeconomics, Biosimilars, Fresenius Kabi
On March 23, 2020 protein therapies currently regulated by the FDA as “drugs” under section 505 of the Federal Food, Drug, and Cosmetic Act will transition and will be “deemed to be a license,” and regulated by FDA under section 351 of the Public Health Safety Act. A preliminary list of these products that was compiled by FDA identifies almost 100 impacted products, including human growth hormones, follitropin alfa, hyaluronidase and other products. But the most noteworthy items on the list are the many variants of insulin. Not all provisions of the March 2020 transition have been made public, but FDA has stated that the regulatory impact is likely to be minimal. This transition is expected to spur development of biosimilar insulins. We are hoping that patients will be big winners in this transition with increased access to the life-saving medications.
- Hillel Cohen, Executive Director, Scientific Affairs, Sandoz
The FTC’s civil investigation of the Johnson & Johnson’s contracting practices for Remicade is worth mentioning and monitoring. The alleged strategies employed by J&J to arrange exclusive contracts via bundling rebates/discounts with other products in its portfolio do not appear to be unique to just J&J — at least as it appears on the surface. If the FTC believes that J&J’s biosimilar defense efforts violate antitrust laws though, the ramifications of that decision could lead to significant changes in how formulary placement is negotiated for products when less costly alternatives exist. Even if the FTC sides in favor of J&J, we should have at least three or four infliximab biosimilars available in 2020 that should lead to the type of multisource market share and price deflation that we are accustomed to with traditional generics.
- Matthew Harman, PharmD, MPH, Director of Pharmacy, Employers Health
One promising market development is the formation of a biosimilar oncology market in the U.S. Biosimilar versions of Avastin, Herceptin, and Rituxan have launched and additional versions are due to launch early in 2020. It’s anticipated that oncologists will be less hesitant to initiate therapy with biosimilar versions of these agents and perhaps significantly less averse to switching a patient from an existing oncology agent to a biosimilar version. These drugs are used in a much more episodic fashion as opposed to the chronic nature of diseases treated by rheumatologists and gastroenterologists. About 50 percent of medical oncologists are based in hospital practices and 50 percent in clinic practices. Those oncologists practicing in hospitals are well aware of the formulary processes in place in acute care settings and, therefore, are more likely to adopt a formulary position that’s aligned with the hospital’s budgeted goals. The biological oncology spend is approximately $10 billion per year in these settings and could benefit from meaningful cost reductions.
- Ross Day, Consulting Hospital Pharmacist, Former Director of Pharmacy, Vizient
The U.S. market accounts for an ever-bigger proportion of the global market for biologics and must become likewise for biosimilars. Absent that, I fear for the future of the competitive biologics market emerging in the U.S. in a manner that can mitigate some of the more Draconian solutions being proposed politically that could damage innovation. The emphasis on international solutions may become considerably more visible in 2020 and hopefully used to focus on constructive free-market solutions for biologics writ large.
Fundamentally, we have to reduce the friction between the use of biologics based on their path to approval and need to be able to better recognize their value over the longer term. Otherwise their role in reducing the burden of disease can never be valued, and suboptimal care through delays in access will continue in the U.S. as well as the rest of the world.
- Gillian Woollett, Senior Vice President, Avalere Health
We look to the time when, on a case by case basis, it may not be obligatory to pursue a Phase 3 clinical trial to obtain registration for a biosimilar. This may occur later than 2020. Such a regulatory framework would decrease the cost barrier to biosimilar developers, promote competition, allow sales at more competitive prices and offer years-earlier benefits of improved biosimilars access to patients. This development would also promote decreased costs for payors, whether they be public health care agencies or private insurers.
Five trastuzumab biosimilars that have already received FDA approval will enter the U.S. market in quick succession, likely by the end of 1Q2020 — Mylan’s Ogivri, Celltrion/Teva’s Herzuma, Samsung Bioepis/Merck’s Ontruzant, Pfizer’s Trazimera and Amgen’s Kanjinti. This will be the first time the U.S. will experience such a highly competitive biologic market in a single product class and has the potential to drive very meaningful reductions in oncology expenditure and improve patient affordability to an extent not seen before. Previously we’ve only ever seen two biosimilars competing in the same molecule class, which has just recently increased to three for pegfilgrastim biosimilars.
- Noelle Sunstrom, CEO, NeuClone
One development worth watching in 2020 will be the opening of the pathway for biosimilar insulin. After the passage of the BPCIA in 2010, follow-on versions of insulin were considered under the Hatch-Waxman Act. But biosimilars didn’t fit neatly in the generic category. The BPCIA specified that 10 years hence, on March 23, 2020, applications for biologics (like insulin) previously regulated under the Hatch-Waxman Act would be deemed to be licenses for biologic products.
This year, the FDA issued draft guidance clarifying “what data and information may – or may not – be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product.” Because the agency “expects the risk of clinical impact from immunogenicity to be minimal for certain proposed biosimilar and interchangeable insulin products,” it “recommends . . . that, under certain circumstances, a comparative clinical immunogenicity study would not be necessary.”
There are many reasons for the lack of competition in the insulin market. But it will be worth carefully monitoring this development to see if the FDA is correct that a biosimilar insulin pathway “may result in a more efficient development program that could ultimately bring biosimilar or interchangeable insulin products to the market more quickly.”
- Michael Carrier, Distinguished Professor, Rutgers Law School
Call me an optimist but I believe 2020 will be the year in which scientific alignment on biosimilar development will evolve. Specifically, the scope and extent of comparability clinical trials will likely draw a lot of attention. The winds are blowing in that direction; the most important conversations are fueled by the extensive amount of biosimilar medicines assessment experience by the EU and other medicines agencies globally.
Regulatory science and analytical technology capabilities are advancing and can contribute to making development faster without compromising quality, safety, or efficacy. This has a direct impact on making medicines available and accessible earlier and for more people.
- Julie Maréchal-Jamil, Director Biosimilars Policy & Science, Medicines for Europe
We anticipate seeing more therapeutic oncology agents launching in 2020, which will be an exciting market event to observe. We hope this introduces even more patients to the benefits of biosimilars, and we expect oncologists to be very engaged in driving biosimilar utilization.
- Molly Burich, Head of Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim
There are 13 biosimilar products to seven originator products that have launched in the United States. We’re expecting that number to rise to about 15 before the end of the first quarter in 2020, nearly doubling where we were this time last year. Many of these launches will lead to a significant increase in competition for specific disease states and multiple reference products. In fact, for the first time ever, there will be more than two biosimilar products competing in a market in addition to the one innovator product. To put this into perspective, the launch of Ziextenzo this past year marked the very first time the United States had three biosimilars competing in one category.
We anticipate that these launches will pave the way to the creation and adoption of additional biosimilars. This competition will likely push larger institutions and payers towards making significant decisions on including biosimilars in their formularies.
As the platform expands, we will likely see more manufacturers commit to investing in these products and, ultimately, expanding accessibility.
- Rick Lozano, VP, Biosimilars & Integrated Business Development, AmerisourceBergen
One big market development that we are hoping to see in 2020 is the federal government passing legislation that supports the success of the biosimilars market.
From a legislative perspective, there are a few biosimilar proposals currently under consideration by Congress. For example, one proposal would eliminate patient out-of-pocket costs for biosimilars under Medicare Part B regardless of the patient’s type of coverage and without any changes to the underlying coverage. This is included in the Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act. Additionally, requiring CMS to provide an enhanced ASP-based reimbursement to providers for a five-year period, from ASP+6 percent to ASP+8 percent (of the reference product ASP). This is included in the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM Act) that was rolled into the Lower Drug Costs Now Act.,
- Brian Lehman, MBA, MHA, RPh., Director, Medical Account Management and Strategic Alliances, Sandoz
The major market milestone that may fundamentally shift the Canadian market would be for the largest province in the country – Ontario – to follow the British Columbia government’s policy. Ontario is Canada’s most populist province representing close to 40 percent of the Canadian population. Thus, any policy change in Ontario is likely to reverberate throughout the country. There is also a lot of anticipation in the Canadian market for the arrival of the Humira biosimilar. As one of the most highly used products in the country, a Humira biosimilar could add substantial savings but also reinvigorate the debate around biosimilar-first policies. Though several Humira biosimilars have already been approved in Canada, none have yet been marketed until the necessary patent disputes are resolved.
- Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada
We know that biosimilars in stringently regulated countries are clinically equivalent to the originator’s product. Thanks to surveys, we know that physician specialists’ trust and interest in prescribing biosimilars have significantly grown over time. And we know that there are well over 700 million patient days of positive clinical experience in Europe. Furthermore, we know how exorbitant the prices are for novel biologics in the U.S. Some understandably argue that the U.S. is subsidizing the use of pharmaceuticals across the entire globe on the backs of our patients and payors.
Knowing all this, how will biosimilar products do at launch and beyond?
Of particular interest to me will be the ongoing debate at the Federal level regarding pharmaceutical price regulations to curb the ever-increasing costs of healthcare in the U.S. Will anything become a reality? And if it does, how could it affect the biosimilar space which is necessary for not only cost containment purposes but also as a stimulus for ongoing innovation?
- Edric Engert, Managing Director, Abraxeolus Consulting
Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020 (current as of August 31, 2019). https://www.fda.gov/media/119229/download (accessed Nov 18, 2019)
Precedent: Section 4104 of the Affordable Care Act (Pub. L. 111–148) waived deductibles, copayments, or coinsurance for certain Medicare-covered preventive services.
Precedent: Section 1301(a)(1) of the Consolidated Appropriations Act of 2018 mandated that, for a period of 6 months, the payment amount for certain pass-through drugs shall be the greater of: (1) ASP+6% based on current ASP data; or (2) the payment rate for the drug or biological on December 31, 2017.