The market for biosimilars is estimated to be reach $ 10 billion by 2015.As a result some of the big companies are making biosimilar development a major initiative. Companies like Pfizer, Teva and Hospira are among the developers trying to get an early jump on the biosimilar drug market.

While Pfizer is set on creating "bio-betters," Hospira is in the process of developing an Epogen biosimilar, and Cipla has inked a number of new deals which will help it build a discount biosimilars franchise. These developers won't have to conduct new trials of their drugs. But they will have to provide data proving that their products are as safe, pure, and effective as the original versions--a requirement that's much more complicated for biologics than it is for pharmaceuticals.

A pathway for biosimilar drugs was approved when the Healthcare Bill was approved earlier this year, but the FDA has yet to set out clear guidelines for development of the copycat drugs.

However biopharma execs will soon get a chance to contribute their thoughts about the new regulations governing the development of biosimilars. The FDA is planning two days of hearings in early November to glean the ideas of interested parties, and there are likely to be quite a few coming from the development side of the business.

According to a draft document the FDA will seek:
? Scientific and technical factors related to a determination of biosimilarity or interchangeability;
? The type of information that may be used to support a determination of biosimilarity or interchangeability;
? Development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products; and
? The scope of the revised definition of a "biological product." And more on guidance development priorities, product exclusivity and user fees.

Though over the next five years, the market for biosimilars will swell to $10 billion, only a handful of players with deep pockets and world-class R&D facilities will be able to play,feel some of the analysts. And that means that most small- and medium-size drug developers will never have a chance of leaping into the new market for follow-on biologics, the point out.

The niche for most small biotechs is taking a preclinical or very early stage candidate to proof of concept, at which point they can make a deal. With biosimilars, the developer will start with proof of concept data and then ramp up the most expensive stage of clinical development, with the added charge of running a likely comparison study to the marketed therapeutic.

It is estimated that it will take eight years to run a biosimilar programme with development costs sliding from $100 million to $150 million. With that much time and money at stake, most biotechs will never get into the game.

Though drug prices make up only 10 percent of healthcare costs in the U.S., and biologics account for just 14 percent of total drug spending. But when a treatment costs tens of thousands of dollars a year, those pursuing healthcare reform are naturally looking at generic biologics as an easy way to cut some substantial costs. The general consensus is that there is a real need for a generic biologic approval pathway, but stakeholders are stuck haggling over just how long biologics should be protected from competition.

In the meanwhile according to some reports, European regulators will be spelling out requirements for copies of antibody drugs next month, paving the way for generic competition in a multibillion-dollar market that includes treatments for cancer and immune system disorders.

According to a spokesperson of European Medicines Agency (EMA), the guidelines on biosimilar monoclonal antibodies would be published after being reviewed by the agency's expert committee on drug approvals in November.

The guidelines will then be open for three to six months of external consultation before being formally adopted, most likely in the second half of 2011, he said.

Up to now, complex biotech medicines have been generally immune from generic competition, unlike conventional pills and capsules. But the regulatory landscape is starting to change, posing a threat to leading biotech groups such as Roche Holding AG and Amgen Inc.

Europe has already approved 13 biosimilars, including copycat versions of human growth hormone, anaemia treatment EPO and G-CSF against low white blood cell levels. Antibodies, however, are a far bigger prize and generic manufacturers are eager to cash in as patents on key products start to expire.

So far, the EMA has received requests for scientific advice on six biosimilar antibodies -- a relatively small number that reflects the difficulties of making such copycat medicines.

"This is much more complicated than the normal generic business, so it will be a lot of work for these companies," he said .

As with the 13 existing biosimilar drugs approved by the EMA, generic companies will have to conduct clinical trials to prove their antibody is similar to the original product on which it is based. "Clinical trials will be required," he said.

Though the US regulatory preparations for biosimilar are further behind than in Europe, leading generic drugmakers are eyeing opportunities in both markets.

Teva already has clinical studies under way comparing its copy of Roche's antibody drug Rituxan to the original in treating both rheumatoid arthritis and non-Hodgkin's lymphoma, a type of blood cancer.

The European patent on Rituxan, also known as MabThera, expires in 2014 and the drug could be the first antibody to face a cut-price biosimilar competitor. Rituxan had sales last year of 6.1 billion Swiss francs ($6.2 billion).

Worldwide sales of all biologic drugs reached some $130 billion in 2009, according IMS Health. With demand growing fast, the potential market for biosimilars could be worth tens of billion of dollars in the second half of the decade as multiple patents expire, opine industry analysts.