As mentioned in my last Blog Post, 2025 revealed something about the market for aBLA’s and in turn the PIV Market.

The First Decade of the aBLA

Appearing in 2013-2014, FDA began to process the Abbreviated Biologics License Application (aBLA) to allow a “generic” manufacturer to produce, manufacture, and market a biosimilar. Of course, a few patent infringement cases followed under the BPCIA. In the first few years, the typical aBLA filer was a brand company already familiar with biologics products. Companies such as Amgen, Pfizer, Celltrion, and Samsung Bioepsis filed applications because they were already set up for biologics in terms of know-how — development, manufacturing, and sales — unlike companies manufacturing traditional generic products.

There were four notable exceptions in the first decade. As the aBLA Market began to develop, Apotex, Mylan, Sandoz and Teva – companies with years of experience filing ANDA’s in the traditional PIV Market – entered the aBLA Market. The fact that these four entered the aBLA Market is no real surprise – they are amongst the largest generic manufacturers with a significant presence in the United States.

More aBLA Filers – What Role did Covid-19 Play?

Over the last two years, and especially in 2025, there has been a notably shift in the biosimilar market. While the brand company filers remain to some degree as well Apotex, Mylan, Sandoz, and Teva, we have seen several more traditional, and smaller, generic companies try their hands at producing a biosimilar and filing aBLA’s. While I don’t know for certain, it appears that the pause of Covid-19 gave some companies the time to reconsider their portfolio strategy and enter what seems to be the greener pastures of a less competitive biosimilar market as the PIV Market seems to be getting more crowded every year.

In 2025, Amgen, the manufacturer of Prolia®/Xgeva®(denosumab) Injection, filed BPCIA patent infringement cases against new filers: Accord, Hikma, Biocon, Dr. Reddy’s, Amneal, and Alkem. All of these companies have been participating in the PIV Market for years and have moved into the aBLA Market as well.

But is the Grass Greener?

Surely, one assumption going into the strategy of filing the aBLA was that it would be less competitive than the PIV Market. I can imagine the slide presentation “and we won’t be dealing with tons of other ANDA filers!” Well, 2025 revealed that this assumption has not held up. As of January 2026, there are 11 aBLA filers that Amgen has sued for patent infringement over denosumab. Another BPCIA product with active patent infringement cases is Eylea®(aflibercept) Injection which has 6 aBLA filers.

Considering the extraordinary efforts undertaken to obtain people, know-how, and processes to build out a biosimilar portfolio – let alone the fact that the sales channels are vastly different than the change-at-the-pharmacy world of molecule generics — I can only imagine the disappointment these smaller companies must feel. Time will tell if they stick with the aBLA or abandon this market to refocus on the PIV Market.