As one expert said, though there are many reasons to praise clinical trials for their contributions to drug development, they may not always be the best method to answer some of the most important biosimilar questions we have today.
Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.
In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.
Here we unpack some of the most impactful RWE releases or efforts implemented over the past year, as well as which of the biggest biosimilar questions were answered over the past year.
When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.
Though the FDA has outlined many promising efforts to help the U.S. biosimilar market grow, the biosimilar industry’s public comments reveal an increasing need for the U.S. government healthcare agencies to take even greater charge of biosimilar policy in 2019.
Humira is said to have recently won a national tender in the EU thanks to a startling 80 percent discount to the pre-biosimilar price tag. However, as the dust clears from the initial news, things are less clear-cut than they may have appeared.
A discussion regarding the challenging decisions Pfenex made in the past year regarding its biosimilar pipeline and the company’s efforts getting its teriparatide follow-on ready for the 505(b)(2) pathway.
I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.
In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.
I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.
An exclusive interview with Brian Hosung Min, an SVP and head of drug substance at Samsung Bioepis. He explains the company’s ongoing efforts to realize a lower COGS, speed up production, and manage risk in biosimilar and novel biologics development.
I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.
It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.
A prediction that a failure of the U.S. biosimilars market could lead to the end of the global biosimilars market begs the question of how we evaluate progress, as well as how such a prediction could be avoided.