Biosimilars Alter Drug Patent Expirations
It will come as no surprise that every year, dozens of branded pharmaceutical products lose their patent protections in a process that routinely paves the way for cheap generics.
However, one thing is very different these days, and that comes in the form of biosimilars. According to Fierce Pharma, in the past, patent expirations brought immediate generic competition and the sales hit that come along with them. But, biosimilar development offers a more expensive and complicated proposition, with a patent lost not necessarily opening the gates to copycats.
Coming in as the top entry is Roche’s megablockbuster Rituxan. The drug’s patent expiration comes as a biosimilar threat to that company continues to rise, forcing Roche to look to new launches for growth.
Next up is Amgen’s Neulasta, a white blood cell booster that could well face biosimilar competition this year from Mylan, that’s if its version wins FDA approval. Although the drug’s patent expired in 2015, biosimilar’s have failed to make it past FDA gatekeepers.
It is with examples like these, where a patent is newly lost but biosimilars are uncertain, or where IP protections are already down but the brand still doesn’t face head-to-head copies, the criteria for inclusion in this report better reflected the generic and biosimilar threats.
In addition, another straightforward loss is Pfizer’s legendary Lyrica. Its market exclusivity expires with a December patent loss.It’s important to bear in mind that it’s not just the big giants who are suffering, products from companies large and small face 2018 patent expirations. The report features treatments that have sparked controversy, Allergen’s Restasis, as well as Lilly’s Cialis.
Thanks to complex patient shields, litigation, and regulatory setbacks, the story surrounding each of these patent expirations and newly vulnerable drugs is ever-changing. The report is designed to act as a point-in-time look at the situation surrounding each drug.