FROM BI­O­LOG­ICS TO BIOSIMILARS: THE ART OF EQUIV­A­LENCE

Reader's Digest (Canada) - - Health - D.F. McCourt

Bi­o­log­ics have changed the face of medicine. These drugs — de­rived from com­plex bi­o­log­i­cal sources — have been with us for more than 100 years, but ad­vances in ge­netic tech­nol­ogy have seen the field ex­plode in re­cent decades. As patents on some bi­o­log­ics be­gin to ex­pire, phar­ma­ceu­ti­cal com­pa­nies are bring­ing their own, cost-ef­fec­tive ver­sions of these treat­ments, known as biosimilars, to mar­ket. Health Canada ap­proved the first biosim­i­lar to treat in­flam­ma­tory arthri­tis in 2014, and with biosimilars be­com­ing more in­te­grated in the Cana­dian health care sys­tem, now is a good time for pa­tients to learn more about them.

Dif­fer­ent but equiv­a­lent

Biosimilars, by def­i­ni­tion, are not per­fect molec­u­lar copies of the drugs they mimic. They go through a com­plex pro­duc­tion process and the val­i­da­tion stan­dards for sim­i­lar­ity are ex­act­ing. “The biosim­i­lar mol­e­cules must be demon­strated to have the same ba­sic pro­tein struc­ture, with only mi­nor fold­ing or side-chain dif­fer­ences,” says Dr. Janet Pope, a rheuma­tol­o­gist at St. Joseph’s Health Care and a pro­fes­sor of medicine at West­ern Uni­ver­sity.

“We have data from head-to-head com­par­isons show­ing that the re­sults for pa­tients are sta­tis­ti­cally equiv­a­lent and they are as sim­i­lar as the batch-to­batch vari­a­tion of the in­no­va­tor mol­e­cule.”

The onus of re­spon­si­bil­ity is on drug man­u­fac­tur­ers to demon­strate that dif­fer­ences be­tween biosimilars and the orig­i­nal drug will not af­fect pa­tient treat­ment out­comes mean­ing health care providers can have con­fi­dence in the safety and ef­fi­cacy of the biosim­i­lar as with any other bi­o­logic drug. The costs as­so­ci­ated with them are lower than those of bi­o­log­ics, which is a clear ad­van­tage for pa­tients as treat­ment costs are on the rise. More­over, ac­cord­ing to the Patented Medicines Pric­ing Re­view Board, the use of biosimilars can save the Cana­dian health care sys­tem ap­prox­i­mately $1.8 bil­lion per year.

More choices, bet­ter out­comes

Rheuma­tol­ogy is one of the first med­i­cal com­mu­ni­ties to see re­sults with both types of drugs. In fact, bi­o­log­ics have proven to be ex­tremely ef­fec­tive in man­ag­ing the most se­vere cases of rheuma­toid arthri­tis (RA).

“Bi­o­logic ther­a­pies have rev­o­lu­tion­ized the treat­ment of RA,” says Dr. Bindee Kuriya, Di­rec­tor of the Rapid Ac­cess Rheuma­tol­ogy Clinic at Mount Si­nai Hos­pi­tal. “At the same time, biosimilars are ef­fec­tive and they work in the same fash­ion as the orig­i­na­tor mol­e­cule, so we are quite happy to start a bi­o­logic-naïve pa­tient on a biosim­i­lar.” Some pub­lic and pri­vate drug plans in Canada may be con­sid­er­ing im­ple­ment­ing poli­cies which in­clude the switch from bi­o­log­ics to biosimilars be­cause of their welldemon­strated safety and ef­fi­cacy.

Biosimilars are ex­pand­ing the choices avail­able to pa­tients and health care providers in rheuma­tol­ogy and many other med­i­cal dis­ci­plines, but with greater choice comes a greater need for pub­lic ed­u­ca­tion. That’s why it’s es­sen­tial that pa­tients tak­ing or con­sid­er­ing bi­o­log­ics have an in­formed di­a­logue with their doc­tors about biosimilars and whether they may be an op­tion in their per­son­al­ized treat­ment plans.

“Biosimilars are ex­pand­ing the choices avail­able to pa­tients and health care providers.”

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