Amanda Forys, MSPH, discusses the critical lack of clarity in the US biosimilars marketplace.
Transcript:
Is there a specific policy that’s missing from the biosimilars market?
I think there’s several areas that manufacturers are looking for clarification in and bringing biosimilars to market around the patent dance and a lot of other different things that the FDA still has to put out guidance on. But, one of the biggest payment policy issues that I think is being ignored right now, that will be an issue as more products come to market, is how biosimilar products are being treated under the Medicare Part D. Currently, if you are taking a branded product and you hit the doughnut hole, and you’ve spent, now you’re responsible technically to pay the full cost of your drug—well, the coverage gap is closing now and manufacturers can offer this discount for you to help you get out of the doughnut hole but not have to pay the full cost of your drug.
So, if a drug was $100 before the patient would have paid $100 and that money would have counted toward their true out-of-pocket and gotten them through to catastrophic. Once they get into catastrophic coverage they are only responsible for 5% of their drug cost. Well, with the coverage gap discount program, the manufacturer said, we will now pay 50% of the drug cost, the patient will pay 45% of the drug cost, and then the plan kicks in the final 5%. That’s how the coverage gap will close by 2020. That money though, that the manufacturer is giving to the patient, counts as their true out-of-pocket cost. Biosimilars are not considered branded products in the eyes of Medicare for non-low-income subsidy beneficiaries. So, when they hit that coverage gap, the drug will be treated as a generic product instead of as a branded product. Now the patient will have to pay a higher percentage relative to what they would have paid if the product was treated as a branded product and what the plan is picking up—so now it’s a share between what the plan and the patient has to pay. What the plan is picking up does not count toward that troop and help the patient get into the doughnut hole. Because we are seeing a lot of these products coming out right now that are on the Part B side and not on the Part D side.
There really hasn’t been a final answer on "was that the intent of this or have we just not addressed it yet?" I think manufacturers will be looking for that guidance moving forward. For low-income subsidy patients, a biosimilar is counted as a branded product, so they do pay a higher copay when they access the drug if someone is an LIS beneficiary. So, this inconsistency is definitely something that will need to be addressed in the future. Not just LIS and not LIS but for the Medicare program as a whole.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.