Biotechnology is providing greater opportunities than ever to combat and treat diseases and medical conditions. New brand-name drugs and new biologics; new generics and biosimilars. The term biosimilar is becoming a more common term now. As a pharmacist, I am often asked what is the difference between a generic drug and a biosimilar.
The FDA defines “A generic drug is the same as a brand-name drug in dosage, safety, how it is taken, quality, performance, and intended use.” Biologics and biosimilars are produced in living cells, and a complex multi-step process is involved in their production. A generic drug is a relatively small molecule compared to a biosimilar that is anywhere from 200 to 1000 times larger and is greater in complexity.
Furthermore, biologic medications are developed using DNA technology and genetically engineering a cell is part of the process. Biologics and biosimilars are sensitive to temperature and pH. The nature of these entities does not allow them to be produced on a large scale. A key point here is that a biosimilar cannot be totally replicated to a biologic where a generic drug can be replicated to be identical to a brand name drug. Biologics show great promise in the treatment of cancer and inflammatory diseases such as Rheumatoid Arthritis.
The CMS assigns drugs that are injected of infused a billing code, known as a j-code. It has been their decision to assign all versions of a biosimilar from an original biologic a single j-code.
The Centers for Medicare & Medicaid Services (CMS) are depriving patients of a vigorous and substantial choices for biosimilars at reduced cost and offer more clinical choices.
This decision is hindering reimbursement that could be invested in new treatment and therapies, even greater quality, enhanced reliability, and further research and creativity in the laboratory. Even more concerning is that treatments for a particular illness might not come to market, or the cost becomes prohibitive. Physicians, pharmacists, and hospitals that are reimbursed for administered drugs, often the cost of the medication exceeds the Medicare or Medicaid payment.
To benefit everyone; the patient, the physician, pharmacy, and hospital, CMS should by all means change their policies and set separate j-codes for each and every biosimilar.