IQVIA Data Show ANDA Approvals on the Rise, Biosimilars Fighting for Market Share

During the Association for Accessible Medicines’ Access! 2019 meeting, Doug Long, vice president of industry relations at IQVIA, gave an update about what trends are being identified in the generic and biosimilars markets across the globe.

According to data collected by IQVIA, FDA abbreviated New Drug Applications (ANDA) are being approved at twice the typical rate for the fourth year in a row. According to Long, however, the ANDA backlog is estimated to be around 50% of peak level (nearly 4000) and getting that number down to zero is somewhat unlikely.

Interestingly, though the FDA has been approving ANDAs at an accelerated rate since 2014, the number of ANDA withdrawals has also increased. In 2018, the FDA approved a record number of 735 ANDAs, and the agency also saw a record 71 withdrawals. Furthermore, many ANDA products, once approved, are not being launched. Of the 735 that were approved in 2018, as of December 2018, only 261 had launched.

Long explained that in 2017, spending on medicines in the United States grew 0.6%, notably slower than in years past. Additionally, Long stated that in 2017, there was a 44% difference in the average wholesale acquisition cost (WAC) to net discount for branded protects and a 64% difference for generics. “The most meaningless data point that I’ve ever come across is list pharmaceutical prices,” said Long.

He then moved on to discuss the trends seen in the biosimilar market, both locally and abroad. Long presented data that showed the United States to be among the slowest developed countries to commercialize when the first biosimilar of a molecule becomes available.

“For example, biosimilar [adalimumab] (Humira) launched in Europe in October 2018. We’re not expecting that here [in the United States] until 2023, unless Boehringer Ingelheim figures out their litigation” against the reference product developer, AbbVie.

In terms of market share, Long broke down the data by product per molecule as of January 2019:

Filgrastim:

• Neupogen, 48.0%
• Zarxio, 31.7%
• Granix (a follow-on filgrastim rather than a biosimilar), 20.3%
• Nivestym 0%

Infliximab:

• Remicade, 96.4%
• Inflectra, 3.2%
• Renflexis, 0.4%

Pegfilgrastim:

• Neulasta Onpro, 61.0%
• Neulasta, 38.2%
• Fulphila, 0.8%

Long believes that the lack of biosimilar uptake in the United States “is not a regulatory problem, it’s commercial.” In countries where hospitals or providers are required to prescribe their patient the lowest-cost available option, such as Denmark, biosimilar penetration (as of October 2018) was extremely high. For biosimilar infliximab alone, Denmark reported figures of 98.5% market penetration.

However, the biosimilar market in the United States still holds great potential, he said. From 2019 to 2023, the impact of brand loss of exclusivity is estimated to be worth nearly $95 billion, opening up the market for new biosimilar entry.

Long quoted an industry consultant he questioned about what he sees lies in store for the biosimilar market. He said, “As more and more products come to market, and the products are in wider distribution and there are no identified problems, then perhaps the uptake in the market may improve.”