So…it happened…Donald J Trump has been inaugurated as the 45th President of the United States of America. Those who know me will confirm that I predicted it. When the British people voted for Brexit, I sensed a change in the air. The unexpected and impossible suddenly became the expected and possible. In the UK and US, people have voted for change. Congratulations, Mr Trump…sorry, Mr President! Let’s see where this takes us.
In other news, the FDA published its much-vaunted interchangeable biosimilar guideline. First, congratulations to the FDA for publishing it!
I’ve gone on record and said that there’s nothing in the guideline that leaps out as me as being unreasonable or unexpected. I’m sticking to that, and industry experts have agreed with me.
Some might think that asking for studies against US-sourced reference product makes no scientific sense (and I’d agree to a point). I see this as a practically focused decision. US patients are only ever going to be switched from a US approved reference product, so why allow non-US approved reference product to be used in switching studies? It might make no scientific sense, but I’d appreciate your comments on this.
In terms of the studies that the FDA has asked for, no surprises here either. We need to remember that companies, like Coherus and Momenta, are already doing studies with their respective adalimumab biosimilars per the proposed “integrated study design.” Companies don’t do things in the vein hope that the regulators will agree. The FDA has given scientific advice on these studies. Or did Coherus and Momenta just get lucky?
The guideline also got me thinking on the longer-term relevance of interchangeability. Sure, for some products in the early stages of their commercial life, being interchangeable could be beneficial to some products (e.g. self-injected products, like the anti-TNFs) for some companies (i.e. smaller companies with limited sales and marketing muscle). It could help the product gain traction, drive real world experience.
Longer-term, all biosimilars will be deemed interchangeable with the reference product by payers, even if the FDA doesn’t approve them as such. In some classes the issue of product interchangeability doesn’t even factor into thinking, such is the rapid churn of patients (e.g. filgrastim use in preventing CINV). It’s relevance in the infused product setting is also questionable.
Outside of the US we’re already seeing non-medical switching (or therapeutic substitution, whatever you want to call it). How do you think infliximab biosimilars have done so well in the Nordics? I see this happening in the US as well. Excluding brands in favour of biosimilars, like what Express Scripts and CVS have done with Neupogen and Lantus, will become the norm when the price is right. What was once considered impossible now seems more likely.
On the regulatory front, we’ve seen some more submissions at the EMA and FDA. There have been two bevacizumab biosimilars submitted to the EMA (both are from Amgen/Allergan, per my sources), and another adalimumab biosimilar submission accepted by the FDA and EMA this week.
Congratulations to the team at Boehringer Ingelheim on BI 695501, its proposed adalimumab biosimilar, being accepted for review in Europe and the US; a great achievement. There are currently four adalimumab biosimilars on the CHMP’s January 2017 list of products under review, so have we uncovered who’s behind the “ghost” adalimumab submission I’ve talked about on Twitter?
With Amgen’s ABP 501 (which is behind two, per my source) and Samsung’s SB5 confirmed, and FKB’s FKB327 believed to be behind another (if it’s not, please get in touch, but this is the feedback I’ve been getting), is Boehringer’s BI 695501 the 5th adalimumab biosimilar. I guess we find out in February when the CHMP updates is list of medicines under review.
Finally, a hugely significant court case started in the UK this week. Following a ruling by Justice Henry Carr in December 2016, and a subsequent ruling in early January 2017, FKB and Samsung Bioepis have been given the opportunity to obtain an Arrow declaration which will prevent AbbVie from suing FKB and Samsung in relation to their adalimumab biosimilars. I’m not a lawyer, so I won’t embarrass myself and try and explain the details of the case. Suffice to say, this case has huge implications for adalimumab biosimilars, not just in the UK but across Europe.
Take care peeps, enjoy your weekends!
Duncan (aka @biosimilarz).