By Kirell Lakhman

President Obama's recent proposal to cut nearly in half biologic drugs' patent protection could be a boon to clinical labs that perform assays associated with many of them.

There are at least two reasons supporting my theory.

First, having a greater variety of drugs from which to choose will encourage physicians to prescribe them. And considering that many biologics are used with molecular diagnostics — particularly drugs that work by inhibiting the function of commonly implicated genes, proteins, and enzymes such as CYP2D6, CYP3A, JAK2, EGFR, HER2, BRAF, PARP, FLT3, ALK, and PTEN — testing volumes are bound to grow in lockstep.

Second, and perhaps more importantly, generic biologics will be extremely less expensive, which will be a greater incentive to docs conscious of their patients' health-insurance status. (And, yes, many physicians, particularly specialists, do often ask what kind of insurance a patient carries when considering treatment options. Their goal is to treat or cure them without bankrupting them in the process.)

Obama's proposal was actually "tucked" into the deficit-reduction plan his administration released Monday. The recommendation called for the US Patent and Trademark Office to "reduce the market exclusivity offered to brand-name biologic drugs to seven years … from 12," according to a New York Times blog post.

In fact, the Times' post mentioned the breast-cancer drug Avastin made by Roche subsidiary Genentech, and Herceptin, the gold-standard of biologic drugs used with a companion molecular diagnostic. As it happens, both drugs benefit from HER2 testing, though Herceptin's label requires it.

FDA granted Avastin accelerated approval in 2008 as a combination treatment with the chemotherapeutic paclitaxel in chemo-naive patients with HER2-negative metastatic breast cancer. The drug had previously been approved for colon, kidney, brain, and lung cancers.

But in December 2010, FDA took the recommendation of its Oncologic Drugs Advisory Committee and deep-sixed the drug's breast-cancer indication "because the drug has not been shown to be safe and effective for that use," according to PubMed Health, a database of clinical trial reviews maintained by the National Library of Medicine.

This decision left in the lurch many women with the disease, as well as labs that perform HER2 testing.

But as my colleague Turna Ray wrote in Pharmacogenomics Reporter last month, Genentech had asked FDA to maintain the drug as an option for woman with aggressive disease and limited treatment options — "a subset of patients that could include women with a molecularly distinct, triple-negative form of the disease."

Triple-negative breast cancer patients have hard-to-treat tumors that do not express the genes for estrogen receptor, progesterone receptor, or HER2. According to Ray, during a public hearing in June held to discuss FDA's decision, "several triple-negative breast-cancer patients provided anecdotal evidence of superior response to Avastin."

There is one small issue: FDA has not yet defined the procedures for approving so-called biosimilars, which are quite different from chemical generics. But according to a separate Times article, various generic drug companies and some big pharmaceutical firms are "getting ready."

Bottom line is that at least the stage is being set for "Day of the Biosimilars," and, at least in my opinion, clinical labs will be cast to play a substantial role.

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