All of the major research and development trends are featured in this new list of drug approvals for 2021. Plus one.
Add everything OK from CDER and CBER, and you have 60 new drug approvals for last year, surpassing 59 in 2020. That’s the second close to 64 approved by the Food and Drug Administration in 2018. The dark days of the early 2000s And twenty memories are far away now, with a group of hungry newbies promising to make their own posts one day while Big Pharmas doubles down on innovation.
There’s a new slate of small biotech companies that have proven their first drug approvals, expressing nothing but a desire to get out there and start marketing — something they all have a lot to learn about. Not all of these drugs are tipping the commercial scales, but that doesn’t mean they aren’t important to the young orphans who moved the trend over a decade ago.
Meanwhile, the list of smaller players making the leap now includes biotech companies such as Apellis and ADC Therapeutics. He hit Kadmon, then sold it to Sanofi. Can they perform as the analysts have promised? Hopes and predictions during development are one thing, but as Biogen execs can tell you, sales are an unforgiving hard numbers game.
There are latecomers in the winning column, often showing up at the organizational finish line past the scheduled schedule, sometimes shackled and bruised by CMC issues that still plague the field. The US Food and Drug Administration (FDA) has repeatedly shown that it is not in a tolerant mood about suspicious manufacturing issues. This trend appears to be embedded in the fabric of the drug approval process, for companies large and small alike.
Novartis dealt with that before getting its approval for Leqvio (inclisiran) and will now put its huge shoulder behind the commercial wheel in the LDL market.
Major players, of course, tend to dominate the potentially huge movie slate. This is another industrial tradition. So both AstraZeneca and Amgen have made notable contributions to the list, for breakthrough asthma as well as impressive cancer drugs. AbbVie has made its mark with Migraine, which is seeing a new wave of treatments enter the market.
As always, sheer determination is important to a great deal of success. SeaGen’s success with next-generation ADCs is a case in point. AstraZeneca’s R&D people almost never give up, but they keep fighting forward, changing experiment designs, and they keep on doing it. In this sense, the final completion of its global headquarters in Cambridge, UK in 2021 was a fitting symbol of the company’s intransigence. They may not impress you with speed every time, but they reach the functions of organizational goals.
But amid all the hard work and endurance, let’s not overlook the victories of the year, which were topped by Albert Bourla’s Pfizer. In the face of the pandemic, Pfizer has moved its partnership with BioNTech to legendary status. His mRNA vaccine provided an immediate boost in sales worth tens of billions of dollars. They got there first, breaking down development and regulatory barriers, and creating a franchise that will help transform the multinational for the next decade. And let’s not forget that they did so in a year they brought Prevnar 20, a next-generation approach expected to protect one of its biggest franchises.
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