Comments on: The Battle Over Biologics

By: Michelle

Michelle — Tue, 05 Jul 2011 14:13:36 +0000

Thanks for sharing this with us. Very informative information! I had to go two years with no treatment for my RA because of the cost of these biologics. I am now on Actemra only because of help through a foundation. When that runs out, I’m not sure what my choices will be…

By: Kim (Bailey's Mama)

Kim (Bailey's Mama) — Sat, 05 Sep 2009 17:47:24 +0000

My Daughter Bailey (Almost 5) diagnosed 2 1/2 yrs ago. Has had this affect her eyes several times —– this last month was the worst! Her Remicade bills have been coming in at almost $8,000.00 !!!!!! She was getting these every 2 weeks —so Yea, that comes to @ 16 GRAND a month?!?!!?!!!!! Thats with Insurance —- Blue Cross,….. What are we to do though – She has to have it to keep walking AND to SEE!!!!!! Check out her Blog Page: http://thewarrens-baileysmama.blogspot.com/

By: Prof

Prof — Sun, 19 Jul 2009 03:14:27 +0000

i’m never surprised when i hear about these business schemes as it seems to be normal practice for many companies. the bottom line is all that matters…never mind the people and lives that are affected by the decisions of these companies. it is so infuriating, and i find myself wondering when our elected officials will take a stand against these practices and call them out. this looks like great material for an aspiring documentary filmmaker. anyone out there??

thanks for bringing this to our attention, RA guy!

By: Joy

Joy — Thu, 16 Jul 2009 03:36:57 +0000

I was confuuusssed, but think I got it now.

Even though a biologic’s patent may have expired, the biologic company still has “market exclusivity” because there is no “FDA regulatory pathway” for a follow on biologic or biosimilar (a generic version of a biologic).

So, with no competition, biologic companies can continue to charge whatever they want. Ka-ching!

By: RA Guy

RA Guy — Wed, 15 Jul 2009 17:28:54 +0000

Wonder how the Waxman and Eshoo bills differ on safety?

Waxman’s bill, which calls for an exclusivity period of 5 years, actually calls for more testing. In addition to having to include “(ii) information from any necessary clinical study or studies sufficient to confirm safety, purity, and potency”, it also stipulates that any such studies should avoid any unethical testing. (http://www.govtrack.us/congress/billtext.xpd?bill=h111-1427&version=ih&nid=t0%3Aih%3A43) This proposed legislation also calls for new tests, should any of these medications be introduced for pediatric use. (http://www.govtrack.us/congress/billtext.xpd?bill=h111-1427&version=ih&nid=t0%3Aih%3A238)

Eshoo’s bill, which calls for an exclusivity period of 12-14 years, actually allows for less testing. This proposed legislation allows for the following tests to be waived: analytical studies, animal studies, and clinical studies. (http://www.govtrack.us/congress/billtext.xpd?bill=h111-1548&version=ih&nid=t0%3Aih%3A42)

By the way, Waxman’s Bill (H.R. 1427) has currently has 14 co-sponsors in the house, while Eshoo’s Bill (H.R. 1548) currently has 131 co-sponsors in the house.