Prateek Yadav co-wrote this blog post with Christina Corridon, Tucker Herbert, Didier Chicheportiche and Gustavo Poblete.
The biosimilars market in Europe continues to generate buzz as it captures considerable market share from major blockbuster-branded biologics. Most recently, Celltrion's Truxima, a biosimilar of Roche's MabThera (rituximab), captured 32% market share in 18 European countries. Regulatory agencies have also welcomed biosimilars for the promise of the potential cost savings that they bring. Earlier, the U.K.’s National Health Service reported that switching patients from branded drugs to biosimilars and generics led to a savings of £324 million last year.
Vartika Pandya and Ross Shahinian co-wrote this blog post with Tucker Herbert.
To address healthcare system costs, the Biologics Price Competition and Innovation Act established an abbreviated pathway for less expensive copies of biologic drugs called biosimilars. Biosimilars have struggled to penetrate the U.S. market, including those developed by major players. Biosimilars of Remicade (infliximab) have managed to capture only 6% of the U.S. market 21 months post-launch. By contrast, the EU has witnessed a more rapid uptake of biosimilars, likely due to stronger payer control and regulatory guidelines facilitating biosimilar penetration (such as the NHS commissioning framework for biological medicines in the U.K.). In the U.S., the FDA has followed suit by developing the Biosimilars Action Plan (BAP) to strike a balance between innovation and competition in the U.S. biologics market.
Biosimilars Action Plan,
Disparate uptake of biosimilars to date show that developing a biosimilar is far from a sure bet. Launching any new drug is challenging, but launching a biosimilar can be especially tricky because of the increased uncertainty across regulatory, legal and commercial spheres on one hand and an expectation that significant promotional effort will be required (without being able to differentiate on safety/efficacy) on the other. Is choosing between biosimilars (or an originator) making a therapeutic choice? In the eyes of the FDA, unless a biosimilar has been granted interchangeability, the product choice remains with MDs as the products have been deemed to have equivalent safety/efficacy without being identical. (Other key stakeholders are developing a range of perspectives on this topic.) To ensure commercial success, biosimilar developers (and defenders) need to have a strategic plan for forecasting and conducting market research to fully understand the market complexity. It’s also critical to align the incentives for providers, patients, payers, pharmacists and procurement—all of whom can play a critical role in driving or delaying a new biosimilar’s uptake.
new product launch,
Christina Corridon co-wrote this blog post with Ross Shahinian.
In 2017, there were 46 novel drug approvals in the U.S., according to the FDA. However, the majority (67%) of these drug approvals represent later-to-market entrants that will be vying for share in an increasingly competitive landscape. For example, take Verzenio, Lilly’s CDK-inhibitor for HR-positive breast cancer, which was third to market after Pfizer’s Ibrance and Novartis’s Kisqali. Or Steglatro, the Merck and Pfizer fourth-to-market SGLT-2 drug, which came in after Invokana, Farxiga and Jardiance.
Subsequent entry biologics (SEBs), or biosimilars, have been making a lot of news in Canada lately. While the discussion has been happening for years already, we’ve started to see how regulatory and payer decisions are shaping this new market. We’ve recently seen payers implement coverage inconsistently (such as the “limited use” code in Ontario, mandatory substitution for new starts in British Columbia and preferential listing in some private payers), regulatory bodies update indications (Inflectra now includes Crohn’s disease and ulcerative colitis), and new products launched (etanercept and insulin glargine).
secondary entry biologics,