by Lauren Chase

Biosimilars have made a lot of headway in the pharmaceutical world over the past few years. While they’ve been hailed for their cost-saving potential, many have failed to take hold in the U.S. market. Leaders in healthcare have claimed that the regulatory systems in place will make biosimilars too expensive to continue developing. But 2019 was the biggest year for biosimilar approval yet — with 10 new ones approved by the FDA.

So how much of a discount do biosimilars offer? And how much will you pay with insurance?

This guide gives a complete overview of biosimilars and their prices and includes:

• A rundown of what biosimilars are, and which ones are approved in the U.S.
• List prices of biosimilars compared to their biologic counterparts
• Resources on how to save with copay cards or savings programs
• How biosimilars and biologics are covered by insurance

What exactly are biosimilars?
Biosimilars are basically generic versions of biologic drugs, which are medications made out of materials that come from living organisms. They include many specialty medications, vaccines, and insulins. There are no clinically meaningful differences between a biologic and biosimilar, except that they can’t be substituted for each other by a pharmacist unless the FDA deems them interchangeable. Right now, there are no FDA-approved interchangeable biosimilars, so healthcare providers must write prescriptions specifically for the biosimilar.

Biologics and their biosimilar counterparts treat many chronic and debilitating diseases. They greatly improve the quality of life for patients who suffer from conditions like Crohn’s disease, ulcerative colitis, and many types of cancer. But they are also extremely expensive. If they are covered by insurance, there are usually barriers to accessing them, like step therapy and prior authorizations.

Biologics are also regulated differently by the FDA — their period of exclusivity is for 12 years. This is the period of time when a medication is protected from generic drug competition, or in this case, biosimilar competition. It’s longer than the normal five-year exclusivity period for brand drugs, meaning it will take longer than for a cheaper biosimilar version to launch and compete with a biologic.

What biosimilars are currently approved in the U.S.?
The FDA has approved 26 biosimilars, but only 15 are currently available. Many of them are marketed in Europe or other countries but not in the U.S. yet due to patent or exclusivity laws. Below is a table of all FDA-approved biologics and biosimilars, and whether or not they are commercially available in the United States.

How expensive are biologics and biosimilars?
Because biologics and biosimilars treat rare conditions and are sourced from more complex living molecules than normal drugs, pharmaceutical manufacturers can impose high prices. While generic medications can be 80% to 85% cheaper than brand name counterparts, GoodRx research found that biosimilars are only 10% to 37% cheaper than biologics. Generally, the most recently approved biosimilars are the cheapest.

So how much do these biosimilars actually cost? To answer that, GoodRx research looked at the list price of biosimilars and biologics. The list price is the price a manufacturer assigns as the official price of a drug. While few patients actually pay the list price because they are typically shielded by their health insurance, the price is still a good proxy for the price patients see at the pharmacy.

Below, we break down the monthly list prices for each group of biologics and biosimilars, as well as resources on how patients can save on each drug.

Avastin (Biosimilars: Mvasi, Zirabev)
In 2004, the FDA approved Avastin — a biologic manufactured by biotechnology company Genentech. Avastin and its biosimilars treat several types of cancer. Mvasi, the first biosimilar for Avastin and the first one approved to treat cancer, was approved in 2017. Avastin’s second biosimilar, Zirabev, won FDA approval in May 2019, and only recently became available to patients.

Avastin is one of the most expensive biologics, with the list price reaching up to $12,000 per month. GoodRx found that the list price of Zirabev comes in at a 23% discount compared to Avastin. The list price for Mvasi is 15% cheaper than Avastin.

How to save:

For patients who are taking Avastin or its biosimilars, the dosage ranges from 5 mg/kg to 15 mg/kg intravenously every 2 weeks, usually in combination with other chemotherapy drugs. This means patients could need around 15 vials per month.

• Zirabev: Pfizer’s Co-pay Savings Program for Zirabev can help with up to $25,000 per year on out-of-pocket expenses, but only for patients with commercial insurance. It also can’t be used by patients who are prescribed Zirabev for ovarian, fallopian tube, or peritoneal cancer.
• Mvasi: Amgen’s Assist 360 program helps patients with commercial insurance, and it can also refer patients with government insurance to independent nonprofit programs. Additionally, the Amgen Safety Net Foundation can help patients who are uninsured access this medicine.
• Avastin: Genentech has programs to provide financial help to patients who need Avastin. They have a copay savings card, and they give referrals to the Genentech Patient Foundation, which can provide Genentech medications to people without insurance.

Remicade (Biosimilars: Inflectra, Renflexis)
Remicade, a biologic that treats rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and severe psoriasis, has been available in the United States since 1998. It works to reduce levels of tumor necrosis factor in the body, a chemical involved in inflammation caused by these diseases.

There are two biosimilars approved for Remicade. The first biosimilar, Inflectra, received FDA approval in 2016. The second, Renflexis, was approved in 2017. Renflexis is available at a 35% discount compared to Remicade, and Inflectra’s list price is a 19% discount.

After initial administration, Remicade and its biosimilars are administered intravenously around once every two months as a maintenance medication for the majority of the conditions it treats.

How to save:

• Remicade: Janssen Care Path provides financial assistance for Remicade, up to $20,000 per year. It is only available to patients who have commercial or private insurance.
• Inflectra: The Pfizer enCompass Copay Assistance program helps patients with commercial insurance get financial assistance for Inflectra. Your healthcare provider must submit the application for this savings program.
• Renflexis: Manufacturer Merck provides a copay assistance program for patients with commercial insurance, with a benefit of up to $20,000 per year.

Herceptin (Biosimilars: Kanjinti, Ogivri, Trazimera, Herzuma)
Herceptin is a medication used to treat breast cancer and gastric cancer, and it has been available since 1998. Four of the five biosimilars approved for Herceptin have launched thus far. They include Kanjinti, Trazimera, Ogivri, and Herzuma. One other biosimilar has been approved, Ontruzant, but it has not yet launched.

These biosimilars range from being 10% to 15% cheaper than Herceptin. The cheapest biosimilars are Kanjinti and Ogivri, which are both 15% cheaper than Herceptin for a 150 mg vial. Herzuma, which was approved in 2018, has only a 10% discount compared to Herceptin. Trazimera is not available as a 150 mg vial, but it has the cheapest price per mg.

The monthly list price for Herceptin and its biosimilars is assuming a maintenance dose of 6 mg/kg every three weeks, or about 450 mg per month. For Trazimera, the assumed dose per month is 420 kg or 1 vial.

How to save:

• Herceptin: Genentech, the manufacturer of Herceptin, has a BioOncology copay card that offers up to $25,000 per year toward the medication.
• Kanjtiniti: Amgen’s First Step program helps with copay costs for patients who have commercial insurance.
• Ogivri: Mylan Advocate provides help for commercially insured patients whose insurance plan covers Ogivri.
• Trazimera: Pfizer Oncology together has a copay savings program for Trazimera that provides a benefit of up to $25,000 a year for patients with commercial insurance.

Neulasta (Biosimilars: Fulphila, Udenyca, Ziextenzo)
Neulasta, manufactured by Amgen, was first approved by the FDA in 2002. It’s used to decrease infection in patients undergoing chemotherapy. In short, it works by stimulating the growth of white blood cells in the body.

Neulasta has three biosimilars: Fulphila was approved in May 2018, Udenyca in September 2018, and Ziextenzo in November 2019. The newest biosimilar, Ziextenzo, has the highest discount, with the list price being 37% less than Neulasta. Fulphila and Udenyca come in at a slightly lower 33% percent discount.

When administered to patients receiving chemotherapy, Neulasta and its biosimilars are injected once per chemotherapy cycle.

How to save:

• Neulasta: Patients with commercial insurance can get financial help through Amgen’s Assist 360 program. Patients without insurance can get help through the Amgen Safety Net Foundation.
• Fulphila: Mylan, the manufacturer of Fulphila, provides assistance through their Mylan Advocate program. Eligible patients may be able to get Fulphila for $0 per copay.
• Udenyca: There is a copay assistance program for Udenyca through the Coherus Complete Co-pay assistance program. To be eligible, patients must have commercial health insurance. The maximum annual benefit is $15,000.
• Ziextenzo: Sandoz provides a copay program for Ziextenzo, through their One Source Commercial Co-pay program. Commercially insured patients can get a maximum annual benefit of $10,000.

Epogen/Procrit (Biosimilar: Retacrit)
Epogen and Procrit are the trade names for the active ingredient epoetin alfa, and they were approved by the FDA in 1989. They are used to help treat anemia caused by chemotherapy or chronic kidney disease. The only biosimilar available for these drugs, Retacrit, was approved in 2018.

Currently, a 10,000 unit vial of Retacrit is at a 67% discount compared to Epogen, and an 80% discount compared to Procrit.

For patients with chronic kidney disease, doses can amount to about 9 vials per month.

How to save:

• Epogen: The Amgen Safety Net Foundation may help patients who need Epogen and are uninsured.
• Procrit: Janssen itself doesn’t provide a copay savings program, but they provide many resources for savings, like state-sponsored programs, Medicare savings programs, and independent nonprofits.
• Retacrit: Pfizer Oncology Together may be able to help identify resources for patients with Medicare or government insurance.

Neupogen (Biosimilars: Zarxio and Nivestym)
Approved by the FDA in 1991, Neupogen is one of the oldest biologics. One of its biosimilars, Zarxio, was the very first biosimilar approved by the FDA in March 2015. Nivestym, the second biosimilar, was approved in 2018.

These medications treat neutropenia, a condition where the body doesn’t produce enough white blood cells. They help fight infection in patients who are undergoing cancer treatment.

Nivestym is 37% less expensive than Neupogen. Comparatively, Zarxio is just 18% cheaper.

The dosing schedule for Neupogen can vary depending on what condition the patient is being treated for and how long they are being treated, which is based on a patient’s neutrophil (a type of white blood cell) count. Usually it is administered as a once-daily subcutaneous injection for the duration of treatment.

How to save:

• Neupogen: Patients with insurance can get financial help through the Amgen First Step Program, or Amgen Assist 360 can assist patients who have government insurance, like Medicare or Tricare.
• Zarxio: Manufacturer Sandoz has a copay program for eligible commercially insured patients. Through this program, patients may pay as little as $0 out of pocket per copay.
• Nivestym: Patients can get help for Nivestym through the Pfizer Oncology Together Co-pay Savings Program. Commercially insured patients can get up to $10,000 per calendar year.

Rituxan (Biosimilars: Truxima, Ruxience)
Rituxan was first approved by the FDA in 1997. Initially, it was only used for non-Hodgkin’s lymphoma, but it was soon approved for many other conditions, including cancers, rheumatoid arthritis, and a few other diseases.

Truxima, the first biosimilar to Rituxan, was approved in November 2018, but only for oncology-related conditions. Ruxience was then approved in July 2019. But, like Truxima, it was only approved for some of the conditions that Rituxan treats.

Currently, Truxima is only 9% cheaper than the biologic Rituxan, while Ruxience is about 24% cheaper.

The dosing for Rituxan is based on body surface area, not weight, like most other biosimilars. For non-Hodgkin’s lymphoma, Rituxan and its biosimilars are administered once weekly, and an administration includes 6 to 7 vials.

How to save:

• Rituxan: Through the Rituxan Immunology Co-pay Card Program, commercially insured patients can receive up to $15,000 to help with medication costs.
• Truxima: The Teva CORE Program offers up to $25,000 in financial assistance for eligible commercially insured patients.
• Ruxience: Through Pfizer Oncology Together, commercially insured patients can pay as little as $0 per treatment.

Does insurance cover biologics and biosimilars?
At the very least, insurers will usually cover a biosimilar — according to a 2017 report, 81% of health insurance plans covered at least one biosimilar. But which biosimilar an insurer will cover and how difficult it is to access them is up in the air. Most insurers require you to jump through hoops such as prior authorization or step therapy. Depending on the drug plan, this means that you might have to take the biologic or a different medication before a biosimilar.

When a generic drug launches in competition with a brand, prescription drug plans will usually immediately switch to cover the generic. With biologics and biosimilars, plans are generally much slower to switch from biologics to biosimilars, or companies may not even choose to make the switch at all, only covering one drug in a group of biologics and biosimilars.

Also, since these are specialty medications, some are only administered by a healthcare provider — meaning that your medical coverage would pay for these drugs, not your drug coverage. Either way, exact cost sharing will depend on your individual insurance plan.

Below is a table of insurance coverage for each group of biosimilars for commercial health plans. If a drug is covered, it means that it is on a drug formulary for a particular health plan but is on a high tier or needs prior authorization or step therapy before it is covered. If a drug is “preferred” by a health plan, it will be on a slightly lower tier and have less chance of requiring as many restrictions.

Insurance coverage varies quite a bit between groups of biologics and biosimilars. For example, Neupogen biosimilars are covered more extensively than the original biologic product. But the biosimilar counterparts for Rituxan and Herceptin are barely covered at all.

The bottom line
While biosimilars may offer cost savings, current FDA regulations keep development of them fairly sluggish, and insurance companies may take a while to make the switch to cover a biosimilar.

For now, it looks like the uptake of biosimilars will be slow, and the U.S. will continue to lag behind Europe as they make biosimilars available there that won’t be able to launch in the U.S. for years.

But for patients that need biosimilars, there are still ways to save. Many programs exist to financially help both insured and uninsured patients. GoodRx will continue to track the biosimilar market and update you on new drugs and savings programs as they become available.

Co-contributor: Diane Li

Methodology

Prices in this analysis are the list price, which is the price the pharmaceutical company assigns as an official price for a drug. A one-month supply was calculated based on information from the drug’s website and prescribing information. For drugs where dosage varies by weight, we assumed an average weight of 75 kg.

We looked at the cost for approximately a one-month supply of each drug, but many of these drugs are taken for an extended period of time. The specific dosage of each biologic and biosimilar will also vary depending on the condition it treats.

Insurance coverage numbers are obtained from formularylookup.com for commercial insurance coverage in all locations.