After years of regulatory and legal wrangling, the development of biosimilars is starting to advance rapidly in the United States, particularly in the oncology sector where multiple versions of the most widely used cancer drugs are moving forward.
Thus far, the FDA has approved 5 biosimilars, including 1 supportive care drug for patients with cancer.1
Biosimilar versions of 4 major anticancer therapies are either undergoing regulatory review by the FDA or have completed clinical trials designed to secure their final approval (Table). The FDA is likely to make decisions on biosimilar versions of trastuzumab (Herceptin) and bevacizumab (Avastin) within the next year.
aLaunched in Canada in March 2016.
Table. Evolving Biosimilar Landscape in United States
bGained EMA approval in February.
cApproved by Ministry of Health of Russian Federation in November 2016.
dUnder review by the EMA.
CLL indicates chronic lymphocytic leukemia; CRC, colorectal cancer; DLBCL, diffuse large B-cell lymphoma; EGFR+, epidermal growth factor receptor 2-positive; EMA, European Medicines Agency FL, follicular lymphoma; GEJ, gastroesophageal junction; HER2+ indicates human epidermal growth factor receptor 2-positive; MBC, metastatic breast cancer; mCRC, metastatic colorectal cancer; NSCLC, non–small cell lung cancer; RCC, renal cell carcinoma.
Although each biosimilar product has the potential to save patients and payers hundreds of millions of dollars per year and ease the upward pressure on cancer care costs, efforts to maximize those potential savings face many hurdles. Experts say these challenges include:
- Current regulations require developers of biosimilar medications to provide more evidence than generic drug manufacturers to prove equivalency to reference products.
- Performing the studies needed to generate such support is no guarantee of success. The FDA has rejected 3 biosimilar candidates from companies that thought their applications met regulatory requirements.
- Even biosimilar medications that do reach the market cannot be substituted for reference products as readily as generic drugs can be substituted for the brands with which they compete.
- The complexity of biologic drugs has enabled the makers of reference products to win dozens of patents for each medication and court battles have ensued over whether approved biosimilars can be marketed.
- The difficulty of bringing each new biosimilar product to market limits price competition. The 2 biosimilar medications currently available in the United States only cost about 15% less than their reference products cost before their arrival.
Nevertheless, the market for biological medications is so large that deep-pocketed competitors are spending billions of dollars to bring biosimilars to market. Nearly every blockbuster that’s close to losing its main patent protection faces the threat of several biosimilar competitors. Additionally, there is evidence from other countries that laws and regulations similar to those in the United States will eventually create competition. The European Medicines Agency (EMA) has approved 28 biosimilars2
, and prices for the most duplicated medications have fallen by more than 30%—substantially more, in some cases.
"The long-term outlook for a competitive market that significantly reduces the prices of older medications is still good," Mark Ginestro, a principal with KPMG who follows the biosimilar market said in an interview. “It’s just that most of the evidence we see now suggests it’s going to take significantly longer for that market to develop than many people had hoped.”
The financial stakes could not be higher. Analysts estimate that biologic drugs generate $200 billion globally in total annual revenue and are expected to account for up to 28% of the worldwide pharmaceutical market by 2020.3,4
As a class, these drugs are more expensive than branded small-molecule therapeutics. A 2011 study found that the average daily price of all treatments was $1 for branded small-molecule drugs and $22 for biologics.5