The promise for the future is the delivery of high profile and high-value biosimilar products, which if realized will result in the industry reaching its full potential in relation to the availability of biopharmaceutical products. To achieve this the US will need to define an appropriate regulatory strategy which so far is absent.

The biosimilar area has become increasingly appealing and controversial.  Almost all generic manufacturers are actively involved in developing such products, be it directly or indirectly; however, success will only be found by  those who are patient and have the resources and money to invest right away in lieu of future profits.

Indeed, the future of the pharmaceutical industry is in biotechnology.  Biotech drugs currently conform around 10 to 15% of the pharma market, and the biotech area as a whole is the fastest growing; however, the market must be re-alined if it wants to take full advantage of the large numbers of products that are losing their patents in the next few years.  To date,  the progress has been  slow, with a great vdeal of attention centered on three crucial concerns that will probably determine the future of the whole pharmaceutical market:

1.    A regulatory deal is almost certain
To date,  the nonstop backbiting between the FDA, Congress and interested parties, along with the lack of a regulatory trail for biosimilars in the United States, has contributed to an overwhelming market expansion inside and outside the US.

Although it looks like some tyoe of regulatory deal may be struck this year, no one knows how supportive it will be to the development of biosimilars in the United States in an economically meaningful way.

2.    More valuable product variety is on its way
The Biosimilar products currently on the market are fairly inexpensive; nevertheless, the new ones, including monoclonal antibodies for the treatment of cancer and CNS, should prove to be more appealing and profitable for manufacturers.

3.    Acceptance from physicians

Biological drugs are a complex and an expensive way of treating serious diseases; in some cases this may result in physicians being reluctant to prescribe and use biosimilars as generic drugs.  Some countries, like France and Japanhave already expressed concerns about bioequivalence and are more reluctant than others, making it more difficult for biosimilars to be accepted.

The hope of biosimilar manufacturers is that the market will see biosimilars as therapeutically equivalent and thus, safe to prescribe in place of other drugs.

For branded manufacturers the opposite case is true. Here they hope is that the regulators will name these drugs as completely different drugs that cannot be replaced, thus protecting their branded monopoly.

As a result of these different financial  interests, there is considerable dialog on-going about  INN naming, because products with different INN names are more likely to be considered different and not interchangeable.

In countries where generic products are widely used and physicians know how to prescribe based on INN, biosimilars are expected to have a good acceptance.  The key is to ensure physicians are certain about the safety and efficacy of the drug so that they are willing to change; however, it is likely that an economic incentive will be required to bring this about.

The reason why physicians prescribe generics is to save money, and it is still not certain if biosimilars will generate enough savings..

In regards to patients, they will accept the properly approved biosimilars without a problem; however, they will prefer the newest drug available if it is within their means.

A crucial point in the biosimilar debate is the interchangeability and substitutability, of the products in the different regulated markets.  The legislation before Congress deals with specific provisions that permit the applicants to try to show interchangeability, but the FDA does not like the idea.  In Europe, biosimilars are labeled as having a ‘therapeutic similarity’, but until now, there are no serious efforts to deal with this concern.  Substitutability, which would enable, for example, a pharmacist to offer a biosimilar drug when the physician has prescribed the original, is very unlikely to be accepted.

Life sciences consulting firms are working with their clients to prepare them for the changes ahead and ensure their survival and development of their full potential in agreement with the new perspective in the industry.

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