With commentary by Alissa R. Segal , Pharm.D., RPh, CDE, CDTC, a Clinical Pharmacist at the Joslin Diabetes Center.
Biosimilar insulin promises the same blood sugar control at a lower price, but is it as good as brand-name, and will you really save money?
The first “biosimilar” insulin—made with a formula that copies an approved, name-brand insulin— is set for sale in the U.S. later this year. Now a new study in the journal Diabetes, Obesity & Metabolism says it works as well as the brand-name drug it’s based on. But as insulin costs skyrocket, experts say the “copycat” insulin Basaglar, made by Eli Lilly, may give consumers a small price break—and note that switching may require extra attention to blood sugar levels at first.
The U.S. Food and Drug Administration (FDA) approved Basaglar in late December; it is expected to hit pharmacies in late 2016. The drug has the same basic protein structure as the popular, long-acting insulin glargine Lantus and is made by a similar process. For regulatory reasons, the FDA calls copycat insulin a “follow-on” product, but the drugs are widely described as biosimilars by diabetes experts here and in other countries where they’ve already gained approval or are on sale.
The new study, conducted by Eli Lilly, followed 452 type 1s and 299 type 2s who had been using Lantus and switched to Basaglar. After six months, their blood-sugar levels were the same on the new drug. According to the U.S. Food and Drug Adminstration (FDA), possible side effects with this insulin are in line with side effect risks with any type of insulin and include hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, fluid retention and weight gain. 1
Experts contacted by EndocrineWeb say consumers can expect a small price break when Basaglar goes on sale – with bigger discounts to follow if more biosimilar insulins gain FDA approval. “Nobody expects biosimilar prices to be more than 10-20% lower than brand-name insulin at first,” says endocrinologist Irl B. Hirsch, M.D., a Professor of Medicine at the University of Washington. A 2014 report by the nonprofit Rand Corporation estimates long-acting biosimilar insulins will sell for about 15% less than brand-name versions. If short-acting types come on the market, they may cost about 11% less.2
Biosimilars 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,” explains 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 insulins will work the same way as the analog insulins they’re based on.”
There are plenty of biosimilar insulins in research or on sale elsewhere already. Major insulin makers Merck and Sanofi are testing some.3 Lilly’s Abasaglar, the same drug as Basaglar, is set to go on sale soon in the UK.4 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. Meanwhile, drug companies in China, Poland and India are testing and selling biosimilars in other parts of the world. And biosimilars have been on the market in Poland since 2001, India since about 2003, South Africa since 2005 and Nigeria since 2010 according to a 2015 review in the journal Endocrine Practice.
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 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. “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.”
As with any drug change, Dr. Segal says it’s important to check blood sugar levels more often if you decide to try biosimilar insulin. “Be cautious and do more monitoring,” she 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.”