Biologics, which are used to treat patients with cancer, blood irregularities, psoriasis, and auto-immune and neurological disorders, are the result of complicated biological manufacturing and testing processes. They have as many as 20,000 atoms, and they interact with the body in different ways from chemically-derived medicines.
As a result, it is virtually impossible to make exact copies, but only something very similar. Hence, the generic versions are often referred to as “biosimilars,” “bioequivalences” “biocomparables,” “me-too biologics” or “biobetters.”
The expense and complexity of manufacturing biosimilars also means they won’t be as deeply discounted as generic chemical drugs, which generally cost 50 percent to 90 percent less than the originals. Biologic copies are expected to cost between 10 percent and 20 percent less than the originals.
Although biosimilars are already on the market in Europe, none have yet been approved for the U.S. market (US original patent periods are longer). The FDA has, however, issued draft rules for the approval process. Most expect the first biosimilars to gain FDA approval in 2015.
Notification of Substitutes
But battle lines have already been drawn. Amgen, which makes both biologics and biosimilars, and Genentech have led the efforts to promote passage of state notification laws. Together the two companies contributed about $650,000 to state legislative races in 2012.
Gino Grampp, director of research and development policy for Amgen, said that because biosimilars are not identical to the originals, it is important that physicians be alerted when there is a substitution. Otherwise, if a patient has an adverse reaction to a biosimilar, the doctor may not be able to identify the cause of the problem.
“We aren’t saying the substitution shouldn’t be made,” Grampp said. “We’re saying the doctor should have a record of that substitution.”
State Sen. Jerry Hill, the Democrat who sponsored the notification bill in California, was persuaded by that argument. “In California, there’s real sensitivity to the patient’s right to know and patients controlling their own bodies,” Hill said.
But the generic association argues the proposed legislation is a ruse by the brand-name manufacturers to cause anxiety about biosimilars. “It’s going to raise trust issues and concerns about these medicines,” said Clark of the Generic Pharmaceutical Association. “Why does my doctor have to be specially notified if these drugs are really OK?”
Clark argues that if the FDA approves a biosimilar as interchangeable with the original product, there is no need to create obstacles at the state level. Biosimilars, she argues, should be treated no differently from generic chemical drugs.
Level of Acceptance
Few doctors object to the substitution of generics for chemical medications, but “there’s a real question whether there will be the same level of acceptance among doctors of biosimilars as there are with generics,” said Jack Hoadley, a research professor at the Health Policy Institute at Georgetown University.
Any signal, such as a notification requirement, that suggests biosimilars are not the equal of the originals could diminish confidence in them among doctors and patients.
Meanwhile, the Generic Pharmaceutical Association has found a potent ally in pharmacists, who fear the notification requirement would be a burden. Their opposition was instrumental in the defeat of Maryland state Sen. Joan Carter Conway’s notification bill this year.
“They said it was just too much work,” said Conway, a Democrat.
Stateline is a nonpartisan, nonprofit news service of the Pew Charitable Trusts that provides daily reporting and analysis on trends in state policy.”
Image credit: Wikimedia Creative Commons for sucrose-specific porin
Pages: 1 · 2
More Articles
- National Institutes of Health: Common Misconceptions About Vitamins and Minerals
- A Yale Medicine Doctor Explains How Naloxone, a Medication That Reverses an Opioid Overdose, Works
- National Institutes of Health Launches Home Test to Treat, a Pilot COVID-19 Telehealth Program; Berks County, PA, Is First Community to Join Partnership With Local Public Health Departments.
- Kaiser Health News Research Roundup: Pan-Coronavirus Vaccine; Long Covid; Supplemental Vitamin D; Cell Movement
- How They Did It: Tampa Bay Times Reporters Expose High Airborne Lead Levels at Florida Recycling Factory
- Indoor and Vertical Farming May Be Part of the Solution to Rising Demands for Food and Limited Natural Resources
- A Scout Report Selection: Science-Based Medicine
- Journalist's Resource: Religious Exemptions and Required Vaccines; Examining the Research
- Government of Canada Renews Investment in Largest Canadian Study on Aging
- Kaiser Health News: Paying Billions for Controversial Alzheimer’s Drug? How About Funding This Instead?