What Amgen And Biosimilar Makers Stand To Gain From AbbVie's IPR Win
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Last week, I wrote an article about Amgen’s recent Inter Partes Review (IPR) downfall to AbbVie — a decision which many have declared to be a major setback for biosimilar makers. Indeed, AbbVie’s triumph will likely keep Amgen’s Humira biosimilar from launching in the U.S. in 2017. Amgen has already voiced its plans to continue fighting these patents in court, though this will likely be a time-consuming and costly endeavor for both parties involved.
Despite these obvious setbacks, I am hesitant to view this particular IPR ruling as a sign of doom for the greater biosimilar industry. In fact, there is a way to look at this recent event in a positive light, if you consider which party is stepping up to the plate to fight for biosimilars. After all, it seems like just yesterday when Amgen was arguing in Amgen v. Sandoz that biosimilar makers need to be transparent about their manufacturing processes to ensure no reference product patents have been infringed upon. However, now we’re seeing Amgen taking the offense to eliminate the very patents it is also trying to protect from biosimilar makers.
I’ve always found the reference-product-sponsor-turned-biosimilar-maker to be an interesting animal. It’s not unusual that companies with skill developing biologics would choose to tackle biosimilars; otherwise, why would AbbVie’s announcement that it didn’t plan to develop its own biosimilar portfolio come as such a surprise to the industry? But the increasing growth of the biosimilar market has introduced an unusual conflict for innovators. As Courtenay Brinckerhoff of Foley & Lardner LLP says in her article on Lexology, “Unlike the world of small molecule drugs where most companies consider themselves to be primarily an ‘innovator’ or a ‘generic’ company, in the world of biologics, the same companies are leading the way on both sides of the originator/biosimilar divide.”
We’re facing an interesting business model here. Amgen lost this recent battle. But it’s refreshing and encouraging to recognize that a reference product sponsor will fight as hard as Amgen is preparing to for biosimilars, despite the fact biosimilars are threatening some of its own products. Navigating an identity as both an innovator and biosimilar maker does pose some unique challenges. For one, an innovator-turned-biosimilar-maker is put in the position of shaping a market that is both a source of dangerous competition and an important business opportunity. As Brinckerhoff states, “The probability of finding themselves on both sides of antibody/biosimilar disputes may make companies more cautious about the positions they advance, or at least pause to consider the potential implications when they are on the other side.”
Brinckerhoff puts it perfectly in saying that innovator companies will also see the industry from the biosimilar maker’s perspective. Indeed, there are already questions about how Amgen will handle the patent dance with AbbVie given its innovator-centric argument in Amgen v. Sandoz. After reading Brinckerhoff’s perspective, I’m choosing to approach this recent IPR stumbling block with a dash of optimism. In the bio space that seems split, innovator vs. biosimilar maker, seeing companies learning to navigate the market from both sides suggests we could someday see a more even and unified playing field between reference drugs and biosimilars.