Observing Patients Online: the Changing Face of Research02 Nov 2011 • by Natalie Aster
The market for biological medicines, measured by sales, was worth over $100 billion in 2010, and is highly profitable and growing fast. This market, therefore, represents a great temptation for makers of “biosimilar” products who want to capture market share by introducing cheaper ‘generic’ copies of existing biologics. Biosimilars, though, have not proved as lucrative as the pioneers had hoped, and so many companies are now shifting their sights to “biobetters” – products similar but superior to the branded reference product.
Biobetters share the same low development risks as biosimilars, but can command a higher price due to the added value they provide from the benefit they offer relative to the reference brand. Some, however, suggest that there is no such thing as a biobetter and that the word is merely a marketing gimmick, arguing that Branded Biotech companies have been making incremental innovations for years as part of their life-cycle management strategy.
New phenomenon or not, there is mounting interest in biobetters, and many companies have publicly expressed their intention to move in this direction. It is likely that Branded Pharma and Biotech will be at the forefront of this still very much emerging industry, as will the larger generics companies that already have a finger in the biosimilars pie. Collaboration and alliance with smaller biotech, with the requisite technology and skills, is another eventuality on which there is much agreement.
There are definite advantages to being in the market for those that can bring something new to the table, but there are many potential obstacles along the way. The report “Observing Patients Online: the Changing Face of Research” by FirstWord highlights the important issues that companies will need to consider when trying to chart their route past these obstacles, and identifies some of the important technologies and biotech players who might become the leaders of the new industry. A series of interviews with industry experts throws light on these questions and provides an insight into the probable future shape of the industry.
Observing Patients Online: the Changing Face of Research
Published: September 2011
Price: US$ 595.00
Report Sample Abstract
Clinical trial requirements likely to be biobetter specific
The development costs of a biobetter will differ in some ways from those incurred in development of a biosimilar since the aim is no longer just proof of similarity. The question then is whether this will influence their attractiveness to companies with a potential interest in developing or marketing them.
Not everyone feels that the development process for biobetters will be more difficult. The Development Director of a UK specialist Biotech company compared the two approaches. “If one wanted to mimic exactly, for example, the Roche process for making Pegasys, it could be very difficult to reproduce. The chemistry that they use means that there are a large number of isomers. They will have a process in place with a lot of in-house expertise, which means that they can meet their own specification for the compound. For a generic company to attempt to make Pegasys and meet the same tight, analytical specifications would be extremely difficult. From this perspective, it might be easier for a company targeting this molecule to make a biobetter rather than a biosimilar” (author’s emphasis).
While most agree that a substantial clinical trial program will be required to gain biobetter approval, the extent of the studies is likely to depend very much on the product itself, and just how different it is from the reference brand.
Opening up new markets
Should biobetters carve out a new market for themselves, however, the complications of competition with branded originals and biosimilars could be considerably reduced. It has been suggested that biobetters could offer the potential for ‘treatment extension’ in chronic conditions where patients often become treatment resistant.
Jesus Zurdo says, “The market for these conditions would saturate, unless the biobetter opens a new market.” Regarding the possibility of treatment extension, “You have a new drug that extends that period or can be used as a replacement therapy for patients that become resistant to the first. I think clearly there is a market there. Or if you have a new drug that allows you to treat a patient population that before was not feasible for some reason.”
Market access strategies
On the basis of primary research, FirstWord would suggest that biobetters may be assigned to one of two groups based on the manufacturer. Those made by the originator as a life-cycle management strategy, and historically referred to as second-generation biologicals, may be classed as ‘traditional biobetters’. Conversely, biobetters launched by third-party manufacturers, in direct competition to the original branded product would be ‘biobetters proper’.
Interestingly, one interviewee raised the possibility that one aspect of biobetter marketing strategy might differ, depending on whether the product was a traditional biobetter, or a biobetter proper.
Multinational interest in biobetters – the usual suspects?
According to Rader, “The major players in biobetters will be current innovator companies. Biobetters are innovative products and established innovators will surely all pile in and develop and/or license-in biobetter candidates. These companies have the expertise, R&D, manufacturing and marketing infrastructure to get biobetters on the market the quickest and also get the most profit from these products.”
This view is seconded by a Development Director of a specialist Biotech company “In the end, Big Pharma are going to be the ones able to take the later-stage clinical programs through the fastest.”
Companies such as Amgen have already established themselves as key players in the field of traditional biobetters with products such as Neulasta (pegfilgrastim) and Aranesp (darbepoetin alfa). Roche told the Wall Street Journal that biobetters will form part of its defense strategy against biosimilar competition to Herceptin (trastuzumab) and MabThera (rituximab).
More information can be found in the report “Observing Patients Online: the Changing Face of Research” by FirstWord.
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