Why so lit­tle re­lief on pricey bi­o­logic drugs?

Daily Local News (West Chester, PA) - - BUSINESS - By Linda A. John­son AP Med­i­cal Writer

Drugs made from liv­ing cells, in­stead of by mix­ing chem­i­cals, have brought ma­jor ad­vances since the late 1990s to the treat­ment of var­i­ous can­cers, im­mune sys­tem dis­or­ders, growth hor­mone de­fi­ciency and eye dis­eases.

But the drugs, called bi­o­log­ics, of­ten have enor­mous price tags — up to hun­dreds of thou­sands of dol­lars a year, with crush­ing out-of-pocket costs for many pa­tients. Part of the prob­lem is that un­til re­cently there was no sys­tem in place for U.S. reg­u­la­tors to ap­prove cheaper “generic” com­pe­ti­tion for these treat­ments be­cause ex­act copies can’t be made.

A 2010 law al­lows near-copies, known as biosi­m­il­iars, after 12 years of mar­ket ex­clu­siv­ity for the orig­i­nal. While it’s still iron-

ing out some de­tails of its ap­proval process, the Food and Drug Ad­min­is­tra­tion has ap­proved three biosim­i­lars over the past year and a half.

But fi­nan­cial re­lief has been slow to come. Com­peti­tors have been kept off the mar­ket by reg­u­la­tory red tape and drawn-out law­suits be­tween com­pa­nies de­vel­op­ing biosim­i­lars and cre­ators of orig­i­nal bi­o­logic drugs, who are des­per­ate to pre­serve bil­lions in rev­enue.

So far, only one biosim­i­lar is avail­able in the U.S., a No­var­tis drug called Zarxio that’s a copy of Am­gen’s Ne­u­pogen, for pre­vent­ing in­fec­tions in peo­ple get­ting chemo­ther­apy or ra­di­a­tion treat­ment. By com­par­i­son, more than 20 biosim­i­lar ver­sions of seven bi­o­logic drugs are avail­able in Europe.

Late last month, FDA ap­proved No­var­tis’s Erelzi, a near-copy of Am­gen’s En­brel, but it likely won’t launch un­til after a trial sched­uled for 2018. In April, FDA ap­proved Pfizer’s In­flec­tra, a copy of John­son & John­son’s Rem­i­cade, open­ing the door for it to launch Oct. 3. But Pfizer says only that it is aim­ing for “some­time in 2016,” and J&J’s planned ap­peal of a judge’s de­ci­sion last month in­val­i­dat­ing Rem­i­cade’s key patent could drag on for a year or more.

Rem­i­cade and En­brel, Dr. Bert Liang two of the world’s top-sell­ing drugs be­cause of their steep prices, treat rheuma­toid arthri­tis, pso­ri­a­sis, coli­tis and other im­mune sys­tem dis­or­ders.

Dr. Bert Liang, chair­man of the Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion’s Biosim­i­lars Coun­cil and CEO of drug de­vel­oper Pfenex Inc., re­cently spoke with The As­so­ci­ated Press about ac­cess to biosim­i­lars. His com­ments have been edited for clar­ity and length.

Q

: Why is the U.S., where many bi­o­logic drugs were de­vel­oped, so far be­hind Europe in adopt­ing biosim­i­lars?

A

: A large de­gree of it was (await­ing FDA) guid­ance and stream­lin­ing of the reg­u­la­tory process. Branded (bi­o­logic drug­mak­ers also) are try­ing to uti­lize lob­by­ing ef­forts in­side the Belt­way, as well as the courts, to de­lay the in­tro­duc­tion of biosim­i­lars. They want to keep their mar­ket share.

Q

: When will biosim­i­lars fi­nally take off in the U.S.?

A

: There’s a myr­iad of biosim­i­lars cur­rently in de­vel­op­ment, at least 50. In less than three years, you’re go­ing to see mul­ti­ple.

Q

: Im­por­tant ques­tions are un­re­solved, in­clud­ing whether phar­ma­cists in each state will be able to sub­sti­tute biosim­i­lars when doc­tors pre­scribe orig­i­nal bi­o­logic drugs. When will these and other reg­u­la­tory is­sues be re­solved so launches won’t be de­layed by months or years?

A

: It’s go­ing to take at least a cou­ple years to get more clar­ity around these le­gal is­sues.

Q

: In Europe, biosim­i­lar drugs have brought sav­ings of roughly 40 per­cent. What should Amer­i­cans ex­pect?

A

: Zarxio’s price is a 15 per­cent dis­count. (Non­profit re­search group) RAND fore­casts dis­counts of 10 to 50 per­cent, de­pend­ing on the num­ber of com­peti­tors. Sav­ings up to $40 bil­lion are ex­pected in the U.S. by 2020.

Q

: Are there any ben­e­fits be­yond lower prices?

A

: In Europe, there’s been di­rect pa­tient ser­vices in­creases due to the sav­ings. That also frees up re­sources for other new, ef­fec­tive medicines.

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