Getting biosimilars to market – what works and what doesn’t, Part 3

Case studies: how to make the move to biosimilars.

May 21, 2021

News about biosimilars is everywhere. Sometimes you just need the basics. This three-part series gets you what you need to know. Part 1: What’s what in biosimilars? Compare and contrast. Part 2: Top 10 acronyms in drug pipeline content. Part 3: Getting biosimilars to market–what works and what doesn’t.


To submit a biosimilars application, a biosimilar manufacturer may invest $100 to $200 million, and five to nine years. (By contrast, bringing a new generic drug to market might cost $1 to $5 million, and take just three to five years to win approval.)1

It’s not unusual to have ten or more manufacturers producing the same generic drug. But huge time and financial investments are required to produce a biosimilar. That means that only a few biosimilars will be produced in any drug class.

Shifting the market can be slow going

Generic drugs weren’t easily accepted back in the 80s and 90s. Brand-name drug manufacturers resisted because generics ate away the brand-name drugs’ market share, and thus profits. It wasn’t until 2002 that the percentage of generic prescriptions filled passed 50%.2

Today, more than 90% of all prescriptions filled in the United States are generic drugs. Generic drugs deliver tremendous savings for consumers; they typically cost 80 to 85% less than the brand-name versions of the drugs.3

Brand-name biologics are still preferred for most benefit designs

In 2020, a Journal of American Medical Association study looked at benefit designs for 17 major health plans. These plans represented 60% of Americans covered by commercial health plans.

  • Ten of the 17 plans chose not to offer preferred coverage for biosimilars.4
  • Just two of the plans made biosimilars a preferred choice half of the time or more.4

In February 2020, the FTC and FDA announced new efforts to better support a competitive market for biosimlars.5

Many biosimilars in one drug class help create pressure on the reference drug

Five of the biosimilars launched in the United States are in one drug class, called granulocyte-colony stimulating factor, or G-CSF. This drug class treats neutropenia, a condition that’s often a side effect from cancer. About 11,000 patients every year take a G-CSF drug, generally for about six months. But because it’s for patients with cancer, there’s a continuous entry of new people who need a G-CSF drug, every month, every year.6

G-CSF biosimilars are priced 10 to 30% lower than their reference biologics. The FDA review affirms there’s no clinically significant difference between a biosimilar and its reference biologic.7 A biosimilar offers savings while delivering the same health outcomes. One would then expect that health plans and payers would convert quickly to the biosimilars, right? Wrong. Unfortunately, the conversion to a biosimilar is still a tough sell.

Preferring biosimilars makes a big difference in market adoption rates

Following a September 2018 recommendation from Prime, three Blue Plan clients changed their medical policies to prefer the biosimilars over the reference drug in the G-CSF class. This medical policy change went into effect starting in the first half of 2019. Prime’s other Blue Plan clients added the biosimilars to their formularies but made the selection neutral.

By year-end 2019, the formulary-neutral Blue Plans saw biosimilar conversions at about 18%. But the three Blue Plans who took an active management approach – preferring biosimilars – they saw high conversion rates. They had biosimilar rates of 70%, 73% and 97%. Collectively, this delivered a cost savings of $4 million.

Implementation of G-CSF preferred biosimilar strategy for three Blue Plan clients in 2019

Implementation of G-CSF preferred biosimilar strategy for three Blue Plan clients in 2019

Share of biosimilars by Blue Plan following first year implementation


More savings are still possible.

Looking ahead

Continuing education opportunities on biosimilars will improve physicians’ and pharmacists’ ability to provide appropriate information to help patients make informed care decisions that include biosimilars.8

A biosimilar will not be automatically substituted for the biologic. The doctor will need to prescribe the biosimilar. (Generics could be substituted for the brand-name drug by the pharmacist at the pharmacy. This made growing the generics market much simpler.)

Benefit design elements — like preferred drugs, reimbursement contracts with providers, and more — will have more influence on how quickly biosimilar drugs are accepted and used.

In some ways, we face the same resistance with biosimilars today that we saw in the past with generics. Except now, instead of switching to generics for treating high cholesterol or high blood pressure, we’re asking consumers to switch from a biologic to a biosimilar for treating cancer (as an example). It’s a bigger decision.

We need the same kind of education campaigns around biosimilars that were seen around generics in the ‘90s and the ‘00s. The audiences now, however, are more targeted, since biologic products are used by fewer members and prescribed by fewer doctors.

Prime promotes the use of lower cost drug options such as biosimilars – always with the goal of improving health outcomes and lowering cost of care.


References

1. Biosimilar development requires time and financial investment. © 2020 Pfizer Inc. Accessed at: https://www.pfizerbiosimilars.com/biosimilars-development#:~:text=While%20biosimilars%20have%20the%20potential,million%2C%20not%20including%20regulatory%20fees.

2. 30 Years of Generics. By Ann M. Thayer. September 29, 2014. C&EN. American Chemical Society. Copyright © 2021 American Chemical Society. All Rights Reserved. Accessed at: https://cen.acs.org/articles/92/i39/30-Years-Generics.html

3. The Case for Competition: 2019 Generic Drug & Biosimilars Access & Savings in the U.S. Report, Association for Affordable Medicines. Accessed at: https://accessiblemeds.org/sites/default/files/2019-09/AAM-2019-Generic-Biosimilars-Access-and-Savings-US-Report-WEB.pdf.

4. “Biosimilars got the cold shoulder from health plans when it came to preferred coverage,” By ED SILVERMAN. STATNEWS @Pharmalot. MAY 20, 2020. Accessed at: https://www.statnews.com/pharmalot/2020/05/20/biosimilars-biologics-health-coverage-drug-prices/

5. The FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans. Feb 2, 2020. FDA.gov. Accessed at: https://www.fda.gov/news-events/press-announcements/fda-and-ftc-announce-new-efforts-further-deter-anti-competitive-business-practices-support

6. https://www.primetherapeutics.com/en/news/prime-insights/2020-insights/insights-2020-never-give-up-on-biosimilars.html

7. What is a biosimilar? U.S. FDA. Accessed at: https://www.fda.gov/media/108905/download

8. Ismailov RM, Khasanova ZD, Gascon P. Knowledge and awareness of biosimilars among oncology patients in Colorado, USA. Futur Oncol. 2019;15(22):2577-2584. doi: 10.2217/fon-2019-0194.

Related research

Drug pipeline updates

October 14, 2021

November 2021 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to…

Drug pipeline updates

September 30, 2021

Drug Pipeline Quarterly Update: September 2021

These quarterly pipeline wrap-ups include new molecular entity approvals, drugs with approvable status…

Drug pipeline updates

September 12, 2021

October 2021 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to…