By Joshua Stolow
October 3, 2016 at 5:00 am ET
A year ago, a new class of drug entered the U.S. market. These new medications are called biosimilars. This class could do for the cost of drugs what generics have done for traditional medications over time. The FDA has made great strides in developing guidelines for biosimilars, however, there still remain areas that must be addressed to ensure maximum patient safety and efficacy.
Drugs can be created in several ways. Some, such as morphine, are extracted from plants. Others, such as aspirin, are synthesized from chemicals. Another group, biologics, are made by genetically modifying human genes in living cells. Scores of these, such as etanercept (Enbrel), are used by more than 300 million people in the United States and worldwide to treat diabetes, cancer, autoimmune conditions such as rheumatoid arthritis and lupus, and gastroenterological conditions such as ulcerative colitis and Crohn’s disease.
Biosimilars are often described as “copycat” versions of patented biologics, however, unlike generics, they aren’t exactly identical to the original drug. It is relatively easy to synthesize aspirin, which contains just 21 atoms. It is much more difficult to make new versions of biologics, which consist of more than 20,000 atoms. If you visualize an ordinary chemical drug as a small house, a biologic is like the Empire State Building in terms of size and complexity, says Dr. Janet Woodcock, a leading biosimilar expert who directs the FDA’s Center for Drug Evaluation and Research.
Given the different manufacturing processes, it is impossible to generate an exact copy of the original product, hence the term “biosimilar” rather than “bioidentical.” Think of wine making. All Merlots come from the same variety of grape. But a Merlot from France likely tastes different than a Merlot from California because of the soil, weather, manufacturing processes, and other factors.
As a rheumatologist for over 27 years, a prescriber of biologics for more than a decade, and the father of a son with ulcerative colitis whose life has been wonderfully transformed by these medications, I am all for their use. But, I am somewhat cautious of biosimilars, at least until the FDA implements key policies that will ensure patient safety.
Just last week, FDA gave the green light to the fourth biosimilar, a drug called adalimumab-atto, a biosimilar for one of the world’s biggest selling drugs, Humira. These drugs will increase treatment options for my patients with rheumatoid arthritis and other difficult-to-treat illnesses such as psoriasis and Crohn’s disease, and individuals like my son, who has been living with ulcerative colitis since age 2.
Biosimilars work in the same way as the original in terms of safety and efficacy, however, due to the complicated nature of the illnesses these drugs treat, prescribing a biosimilar may not be suitable for all patients. For any new biologic, including biosimilars, careful monitoring and reporting is necessary and must continue as they become widely used in the community.
I worry that these drugs are being named in a way that could sow confusion, especially when reporting adverse side effects or other problems.
To date, FDA has approved and named four biosimilars, using two different naming conventions. When FDA approved the first biosimilar in March 2015, it received a nonproprietary name with a meaningful suffix reflecting the manufacturer’s name. When the agency approved the subsequent biosimilars, their nonproprietary names included a randomly generated suffix. To make the drug’s origin more transparent, I believe the suffix should reflect the manufacturer’s name, as was the case with the first biosimilar approved in the US, filgrastin-sndz (Zarxio), made by Sandoz.
Additionally, the product label is a critical tool for physicians to make the best prescribing decisions. While FDA has made significant strides to support fully transparent and clear labels for biosimilars, the draft guidance still does not address the interchangeability of the product nor include the full clinical data submitted in support of the biosimilar approval.
Then comes the question of cost. To make a profit on biosimilars, drug companies will first have to spend money. It typically takes eight to 10 years to develop a biosimilar and costs $100 million to $200 million. By comparison, it takes just three to five years to develop a generic drug at a cost of $1 million to $5 million. While biosimilars will likely provide significant cost-savings long-term, possibly tens of thousands of dollars per patient, it will take years before we begin seeing those savings.
As with any new class of drugs coming to market, there will be a learning curve for doctors, pharmacists, and patients alike. The biosimilar marketplace will not explode overnight, transforming treatment for millions of patients. However, these drugs will likely play a large role in the future of healthcare.
Joshua Stolow, MD, is a rheumatologist, an executive board member for the Coalition of State Rheumatology Organizations, a representative of theAlliance for Patient Access and a scientific advisor for the Biologics Prescribers Collaborative.
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