The company also states that biologics, especially large-molecule biologics, "tend to be produced as mixtures of molecules that differ very slightly from one another, which make them difficult to characterize."
Dr. Kolba pointed out that some pharmaceutical companies started to manufacture generic formulations of their own blockbuster trade-name drugs once the patents expired. Current manufacturers of biologics could do the same. Reducing the price of their products to 10% plus cost would solve the problem of equivalence and alleviate concerns about safety and substitution while dramatically reducing the cost to patients, she said.
At least one manufacture of biologics has plans to do so: Amgen, the manufacturer of etanercept, recently announced its intentions to manufacture biosimilars, an Amgen spokesperson said.
In the dermatology arena, biosimilars would also be welcomed primarily because of cost savings for patients and increased access to these effective treatments, said Dr. Mark G. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, N.Y.
Biosimilars will not be identical to the drugs they replace, "and when tested, they will have to come into a certain narrow window of similarity in terms of both safety and side effects," he said in an interview. The dilemma with the side effect profile is that it may not be fully characterized for years and, in terms of effectiveness, "the dilemma is that they have to be approximately equal to the drug that it is replacing."
For example, a biosimilar for etanercept that is 10% less effective than the original product could make a difference clinically. A biosimilar could conceivably work better than the biologic drug it is replacing, but "if it is too much more effective, it’s not a biosimilar and will have to through a new drug application." Moreover, if it is more effective, it might be more immunosuppressive, raising concerns about more side effects, Dr. Lebwohl pointed out.
Dr. Lebwohl disclosed that he has been an investigator for and the department of dermatology at Mount Sinai has received funds from most of the manufacturers of biologics for psoriasis. Dr. Kolba disclosed that she has been a past consultant or speaker to Abbott, Bristol-Myers Squibb, Genentech and UCB; and is currently an investigator in trials sponsored by Abbott, Amgen, Lilly, Pfizer, Sanofi-Aventis, and UCB.
More on the BPCI Act is available on the FDA website.