The day started with a 5 o'clock alarm call and me feeling remarkably fresh to begin my journey to Frankfurt for this year's CPhI Worldwide event. Unfortunately, the idea of a smooth journey was thwarted fairly quickly with the news at Crewe that the 06:33 train to Manchester airport was canceled. Bad start.
Somehow, I found myself at the boarding gate having fast-tracked through security with speed usually reserved for animals of the four-legged variety. Time for a coffee even―especially as one of the runways at Heathrow was closed causing delays to all in- and outbound flights. Not going well.
Nevertheless, I found myself stood in Frankfurt Messe on October 24 considering my options and hoping I would still be able to make the pre-show conferences planned for the day before the main events. Success!
I was fortunate enough to attend a conference entitled "The challenges and opportunities in biosimilars and biobetters," which offered a rare glimpse into the strategies, concerns and successes to be had in this contentious area. Moderated by Alan Sheppard of IMS Health the conference brought together several schools of thought on the topic, which perhaps mirror the global view. Sheppard classified current thinking on biosimilars under three headings: a mirage, an opportunity with some way to go, and something just around the corner. And taking into account the presentations that followed, perhaps it is a little of all of these things.
Genentech's (Roche Group) Gautam Ganguly gave an excellent, high level account of some of the current challenges of entering the biosimilar market, the level of uncertainty in the US regulatory framework a notable example. The big question here was "how similar is similar?" and the answer is somewhat unclear and product dependent. Ganguly pointed out that, because of complex manufacturing, "the process is the product" with each stage conferring unique properties on the resulting biologic making biosimilars very distinct from small molecule generics. Ganguly also noted the companies entering the biosimilars space, making it seem crowded, with traditional innovators, CMOs and generics companies all vying for the same unpredictable market.
Frederico Pollaro from Richter-Helm BioTec posed the question "make or buy?" and provided some case study examples as to his group's decision-making processes. The key message here was the importance of being aware of the timeline involved and asking if your target biosimilar will still be an attractive option 10 years down the road; new therapies, price erosion and market instability all factors to consider. Pollaro also made clear the opportunity, given the right target, to expand the market and take advantage of potential volume growth.
The final presentation in the conference was delivered by Anjan Selz of Finox Biotech and was, I suspect, inspirational to most. Describing his company as a renegade virtual biotech, Selz wowed delegates with the story of how Finox moved from cell bank to Phase III in just four years, comically noting that "we haven't made any money yet!" Once again, choosing the target carefully was a key message. For Finox, picking a niche product with lower levels of competition was the route taken; follicle-stimulating hormone (FSH), with its specialised market and motivated, informed patients offered a strong business case further justified by its successful history. Selz said that the key to success was creating a differentiating factor, whether through improved stability, formulation, delivery or branding, because to physicians "FSH is FSH" and the word biosimilar has no meaning.
Tomorrow (today for you), the co-located events of CPhI Worldwide, ICSE, InnoPack and PMEC and a horde of attendees will descend on the Messe―the anticipation (and sawdust) is palpable.