Vantage's Annual Preview Gives a Look Ahead to Biosimilars, Drug Pricing in 2019

In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.

The report highlights Pfizer’s PF-05280586, a proposed rituximab biosimilar for which a regulatory decision is expected in the third quarter of the year, as among the most valuable research and development projects of 2019 with its net present value of $3.6 billion. Joining the proposed biosimilar on that high-value list are such heavy-hitters as aducanumab (Biogen’s monoclonal antibody for the treatment of Alzheimer disease), voxelotor (Global Blood Therapeutics’ therapy to treat sickle cell), and valoctocogene roxaparvovec (BioMarin’s hemophilia A gene therapy), among others.

Drugs that face upcoming—but unrealized—biosimilar competition are expected to remain among the top 10 products by sales in 2019. The brand-name adalimumab, Humira, is expected to bring in $20.97 billion, while the reference etanercept, Enbrel, is expected to make $6.65 billion. Avastin, the branded bevacizumab, is projected to earn $6.30 billion. All 3 of these products have FDA-approved biosimilars that have not yet launched because of patent challenges and/or settlements.

However, 1 product, the brand-name pegfilgrastim, Neulasta, is about to face substantial challenges. The report calls pegfilgrastim “the fight to watch in 2019,” as Mylan and Biocon have already launched their biosimilar, Fulphila, and Coherus Biosciences will launch its Udenyca in January 2019. While brand-name drug makers have been thus far able to successfully negotiate with payers in order to retain their market share for their reference products, the substantial discounts for the pegfilgrastim biosimilars may enough to help push their uptake.

Furthermore, says the report, the political will to reduce the cost of drugs is growing in the United States. “It is hard to imagine the environment for these lower-cost biologicals getting any worse, and if lawmakers manage to make any progress in their attempts to drive through structural changes in the US healthcare system the struggling biosimilars industry could be one of the first beneficiaries,” write the authors.

Just how the government will address the cost of drugs remains to be seen, however; as the report points out, while House Democrats may be able to pass legislation that requires direct negotiation on drug prices for Medicare and Medicaid, it is unlikely that the Republican Senate will advance those bills. Compromise may be an option, but, say the authors, “Whether any successful deal can be struck between the White House and House Democrats will depend on Mr. Trump’s willingness to compromise and Democratic leaders’ calculations about whether, if they reject any deal, they could continue to campaign on this issue.”