While there hasn’t been a dispute over it yet, “we are seeing some companies that have these improved biosimilars saying that we have these patents, in case we need to enforce them,” Norman says, adding that ‘There is “a bit of chatter out there, but that’s the extent of it right now.
Nonetheless, this is something Norman is keeping an eye on by following media coverage of the matter and doing informal analysis of patents and applications, and his advice to clients is to keep innovating: always look for new ways to develop your product. .
“If you have an intravenous product, try to rephrase [it] as a subcutaneous product. If you have a subcutaneous product, try to find a way to formulate it in a way that makes it easier for patients to take it on their own, ”he says.
Norman sees everyone in the space getting creative, both legally and in terms of regulatory approvals. Biosimilars take advantage of multiple regulatory filings, a departure from the usual approach of filing product for product and determining next steps if Health Canada has data concerns for one or more of the indications for which the biosimilar is requesting. approval. Today, companies sometimes submit multiple bids for the same product in the hope that another will succeed if one fails.