Life Sciences Blog

Life after the patent cliff: What's next for generics?




As Indian generics producer Dr. Reddy's announced yesterday that they want to boost their involvement in proprietary drugs and biosimilar drugs development, I've been pondering what the patent cliff means for the generic industry and how it defines the strategic choices of manufacturers.

With an avalanche of patents for high-revenue drugs expiring in the last 3 years - take Lipitor (atorvarstatin), for example - or about to expire in the next couple of years, the patent cliff has presented a major boon for the generics industry. However, it also brings with it risks.

After the patent cliff, the number of blockbuster drugs reaching patent expiry will slow down and in many cases they will be biologics or more complicated molecules to copy. Bringing copies of biologics (known as biosimilars) to market is not nearly as straight-forward as it is to bring copies of small chemical drugs to market in terms of development work (and risk), cost and expertise required. And achieving a return on investment from biosimilars is likely to be delayed considering that their market penetration tends to be slower and there is still lack of clarity in terms of prescribing requirements and substitution. Life for generic manufacturers is likely to become tougher after the patent cliff.

So what is the industry doing to prepare itself for life after the patent cliff? I'm looking forward to getting the answer to this and other strategic questions in the generics industry when I attend the European Generic medicines Association (EGA) annual meeting in Madrid next week (25-27 June). Stay tuned for more insights after the EGA meeting.

About The Author

Milena Izmirlieva is head of the Life Sciences research team at IHS Markit. Her areas of expertise include market access, pricing and reimbursement, HTA, generics and biosimilars, corporate strategies, and pharma promotion and advertising.