With commentary by Alissa R. Segal, Pharm.D., RPh, CDE, CDTC, a Clinical Pharmacist at the Joslin Diabetes Center.
Good news for the wallets of the 10 million Americans with diabetes who use insulin: The first “biosimilar” insulin— a copy of the popular, long-acting brand-name drug Lantus— is set to hit U.S. pharmacy shelves later this year. And more types may be on the way. Biosimilar insulin is made with a formula and manufacturing process that copy an approved, name-brand insulin. Right now, consumer and healthcare providers are wondering how similar these new drugs will be to brand-name types and how much money they’ll really save.
New research suggests biosimilar insulin is quite similar to brand-name versions. In a new study published in April in the journal Diabetes, Obesity & Metabolism, 452 people with type 1 diabetes and 299 with type 2 diabetes who had been using Lantus switched to the biosimilar Basaglar. After six months, Eli Lilly researchers found that their blood-sugar control stayed the same on the new drug. And according to the U.S. Food and Drug Administration (FDA), possible side effects with this insulin are in line with any insulin and include hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, fluid retention and weight gain.2
For regulatory reasons, the FDA calls copycat insulin a “follow-on” product, but the drugs are widely known as a biosimilars in other countries where they’ve already gained approval such as the United Kingdom and most recently, Japan.
By any name, biosimilars are hot. These copycat drugs are making headlines and getting attention at diabetes conferences and in educational seminars for doctors and pharmacists. “Patents on some brand name insulins are expiring soon, opening the door to biosimilars,” says healthcare advocate Michelle Katz, LPN, MSN, author of Healthcare for Less and Healthcare Made Easy. “One is approved and more may follow, but they will still have to go through a rigorous approval process. With the same structure, at least in theory these insuins will work the same way as the analog insulins they’re based on."
The price break may be small. A 2014 report by the nonprofit Rand Corporation estimates long-acting biosimilar insulins will cost about 15% less than brand-name versions.1 If short-acting types come on the market, they may cost about 11% less.
“The first in the market may not drop the price very much,” says Alissa R. Segal, Pharm.D., RPh, CDE, CDTC, a Clinical Pharmacist at the Joslin Diabetes Center and associate professor of pharmacy practice at MCPHS University, both in Boston. “And the difference may not be enough to change your copay with health insurance. That will depend on health insurance companies and the pharmacy benefit management companies that negotiate drug prices with insurers, drug makers and pharmacies. If they do reviews and decide that follow-on biologics are more cost-effective consumers may see a price break. But makers of brand-name insulins may also negotiate lower prices to stay competitive.”
If other biosimilar insulins gain FDA approval, competition may cut costs further the experts say. Major insulin makers Merck and Sanofi are testing biosimilar insulins. 2 And Biocon, a drug company based in India, recently announced it will sell its biosimilar insulin Basalog One in Japan and plans to apply for approval to sell in the U.S.3
Are they exactly the same? “With any insulin, I always want patients to understand that these drugs are grown in batches – not manufactured by combining chemicals,” says Dr. Segal. “Insulin is grown using yeast or bacteria cells. There are very rigorous quality-assurance protocols in place, but there can be changes in the cells over time. And that can translate into very small changes from batch to batch. With follow-on biologics like insulin, the manufacturing process is similar to the original – but not an exact copy. So there may be slight differences in the way it affects you.”
“I think the important thing for people to know is that whenever you switch to a new insulin product or any new medication you should be cautious and do more monitoring,” Dr. Segal says. “People with diabetes are really lucky in this respect. You’ve got a way to check right away to see if your medication is working or causing a problem – just by using your glucose meter or monitor. Yes, test strips can be expensive but this is the time to use them. Extra monitoring can give you reassurance or provide information you can use to make adjustments.”
1. Hadjiyianni I, Dahl D, Lacaya LB, Pollom RK, Chang CL, Ilag LL: Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine. Diabetes Obes Metab. 2016 Apr;18(4):425-9. http://www.ncbi.nlm.nih.gov/pubmed/26749289. Accessed April 1, 2016.
2. U.S. Food and Drug Administration: FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes. Published December 16, 2015. Accessed March 30, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm
3. Clinicaltrials.gov: Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (SORELLA 1). Updated March 4, 2016. Accessed March 30, 2016. https://www.clinicaltrials.gov/ct2/show/NCT02273180https://www.clinicaltrials.gov/ct2/show/NCT02273180
1. Rand Corporation: The Cost Savings Potential of Biosimilar Drugs in the United States. 2014
2. UK Medicines Information: New Drugs Online. http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=6234
3. Biocon: Biocon’s Insulin Glargine Receives Regulatory Approval in Japan. Published March 28, 2016. Accessed March 30, 2016. http://www.biocon.com/docs/BioconFFP_Glargine_PR_28032016.pdf?subLink=news&Fileid=467