Biobetters: How Much Competition Should Biosimilar Makers Expect?
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
In the past, I’ve found that biobetters spark several reactions from members of the industry. On a superficial level, the use of the term “biobetter” is frustrating to some because it is an industry-coined term, rather than a regulatory term. (The first use of the word "biobetter" is credited to the CEO of Dr. Reddy’s in 2007.) But more importantly, these biobetters are nerve-wracking for those commercializing biosimilars. Biobetters, which share the same target or action as existing biologics, could be more effective, easier to administer, or require fewer courses of treatment. Not only might this appeal to doctors and patients, but these improvements might also lower the cost of overall treatment.
In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?
How Are Biobetters And Biosimilars Faring Against Each Other?
Like many, I’ve been following Roche’s biobetter efforts to overcome the biosimilar threat. The company has been working to get Gazyva up to speed to beat Rituxan (rituximab) at its own game. So far, Gazyva, like rituximab, has been approved for chronic lymphocytic leukemia and follicular lymphoma (specifically for patients who did not see success from rituximab). But last week, Roche broke the Gazyva success streak. It reported some disappointing news about Gazyva’s inability to beat rituximab plus chemo in diffuse large B-cell lymphoma.
This should’ve served as a morale boost to the biosimilar industry — especially to Sandoz who is awaiting a regulatory decision on its rituximab biosimilar application from the European Medicines Agency (EMA). In fact, this news couldn’t have come at a better time. Just a few days prior to the Gazyva results, Sandoz slipped a brief announcement into its earnings report that its pegfilgrastim (Neulasta) candidate had, for undisclosed reasons, earned an FDA Complete Response Letter (CRL). (This same candidate is currently under review by the EMA. Talk about a frustrating lack of regulatory harmony.)
How The Biobetter Battle Could Play Out
Over the past few days, I’ve been buried eyeball-deep in information I gathered from Dr. Steinar Madsen’s panel on biosimilars at the World Biosimilar Congress USA. (For more information on how Norway came to be the golden child for biosimilar uptake, check out this article.) However, what didn’t quite make its way into that article were the details of the elaborate pricing battles that happened behind the scenes between biosimilar makers and originator companies. We’ve all heard of Orion’s strategy to discount its infliximab biosimilar by 69 percent in Norway. It swiftly won over the Norwegian market and has all but basically run Merck’s Remicade out of the country. So, if it isn’t clear from that example, one of Madsen’s key takeaways was that discounts of biosimilars for long-term treatments need to be large — greater than 40 percent.
Biobetters can offer patients more innovative treatments. Many companies invest in biobetters to get an extension of their brand and, likely, the higher prices that come with them. But if it’s going to take a steeper discount to really boost uptake of biosimilars, it’s highly unlikely a biobetter, priced three, six, or nine (+) times more than a biosimilar will survive the market without a steep discount of its own. In fact, that discount might need to match that of the biosimilar to even garner attention.
A lot of the commentary on biobetters circulates around the fact that they may be more innovative and convenient. But this doesn’t justify the price when there is a cheaper biosimilar that effectively treats the same conditions. Biosimilars compete against their reference biologics, other biosimilars, and biobetters. But while biosimilar makers are keeping their eyes on the fates of biobetter candidates, perhaps it should be the other way around.