As of June 23rd 2017 Biogen announced,
that he Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a positive opinion for IMRALDI® (also known
as SB5, an adalimumab biosimilar). Let’s have a look at this year’s EULAR
Annual Meeting. There have been two publications.
J. Kay and colleagues presented [2]: “IMPACT OF
ADALIMUMAB SERUM CONCENTRATION ON EFFICACY AND ASSOCIATION BETWEEN ANTI-DRUG ANTIBODIES
AND SERUM CONCENTRATION: 24 WEEK RESULTS FROM A PHASE III STUDY COMPARING SB5
(AN ADALIMUMAB BIOSIMILAR) WITH REFERENCE ADALIMUMAB IN PATIENTS WITH
RHEUMATOID ARTHRITIS”. Conclusions: “The presence of ADA reduces Ctrough for
both SB5 and ADL. In both treatment groups, almost all patients without
detectable ADA, but only slightly more than half of patients with ADA, had
Ctrough ≥1.274
μg/mL at week 24.
Efficacy and ADA incidence were generally comparable between SB5 and ADL
regardless of Ctrough level. However, patients with Ctrough ≥1.274 μg/mL generally
experienced greater efficacy of both SB5 and ADL than that in patients with
Ctrough <1 .274="" add="" ctrough="" data:="" g="" in="" let="" me="" ml.="" patients="" some="" span="" the="" with="">≥1.274 μg/mL groups SB5 patients
achieved 32.9 % and ADL patients 43.2 % good EULAR response, SB5 patients achieved
32.9 % and ADL patients 45.2 % low disease activity, and SB5 patients achieved 20.8%
and ADL patients 25.9 % remission. Doesn’t look very convincing to me.
J. Ghil and colleagues presented [3]: “USABILITY AND SAFETY OF SB5 (AN
ADALIMUMAB BIOSIMILAR) PRE-FILLED SYRINGE AND PRE-FILLED PEN IN PATIENTS WITH
RHEUMATOID ARTHRITIS”. Conclusions: “The injection site pain score of
PFS and PFP was comparable with overall preference rate higher for PFP. Both
PFS and PFP were well tolerated with similar safety profiles.”
I guess, we can agree that these two studies won’t
have much impact on EMA’s decision. The decision will be made more on political
than medical issues. I’m not a friend of biosimilars, but I know that I’ll have
to prescribe Imraldi, if, yes if Abbvie is prudent enough to cut prices for
Humira. But why should they act prudently? If you have the number-one
prescribed biologic in the world (Humira), you don’t act prudently but
haughtily. Pride comes before a fall.
Links and References:
[2] DOI:
10.1136/annrheumdis-2017-eular.3348
[3] DOI:
10.1136/annrheumdis-2017-eular.3350
.
Sorry, but the text should read:
ReplyDeleteJ. Kay and colleagues presented [2]: “IMPACT OF ADALIMUMAB SERUM CONCENTRATION ON EFFICACY AND ASSOCIATION BETWEEN ANTI-DRUG ANTIBODIES AND SERUM CONCENTRATION: 24 WEEK RESULTS FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMILAR) WITH REFERENCE ADALIMUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS”. Conclusions: “The presence of ADA reduces Ctrough for both SB5 and ADL. In both treatment groups, almost all patients without detectable ADA, but only slightly more than half of patients with ADA, had Ctrough ≥1.274 μg/mL at week 24. Efficacy and ADA incidence were generally comparable between SB5 and ADL regardless of Ctrough level. However, patients with Ctrough ≥1.274 μg/mL generally experienced greater efficacy of both SB5 and ADL than that in patients with Ctrough <1.274 μg/mL.” Let me add some data: in the patients with Ctrough ≥1.274 μg/mL groups SB5 patients achieved 32.9 % and ADL patients 43.2 % good EULAR response, SB5 patients achieved 32.9 % and ADL patients 45.2 % low disease activity, and SB5 patients achieved 20.8% and ADL patients 25.9 % remission. Doesn’t look very convincing to me.
Oh, now I see it - IMRALDI has ALDI in the name. ALDI is one of the top discount supermarkets in Germany.
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