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29 Jul 2020
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Elaine Soliven, 6 days ago
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
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Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.

Adalimumab biosimilar may fill ‘gap’ in ankylosing spondylitis treatment

Audrey Abella
29 Oct 2019

The efficacy and safety of the biosimilar IBI303 mirrored that of the monoclonal anti-TNFα* antibody adalimumab, thus providing a new and affordable treatment alternative for individuals with ankylosing spondylitis, according to a Chinese study.

“Currently, there is no approved anti-TNFα biosimilar in China … [Our findings show that] IBI303 could effectively improve the condition of patients with ankylosing spondylitis and is therapeutically equivalent to adalimumab,” said the researchers. The findings also imply that IBI303 could be an alternative to the costly adalimumab that may consequently lead to improvement of treatment availability, they added.

IBI303 was compared against adalimumab in a cohort of 438 individuals with ankylosing spondylitis (mean age 32.3 years, 83 percent male) who were randomized 1:1 to receive 40 mg of either drug subcutaneously every 2 weeks until week 22. [Lancet Rheumatol 2019;1:e35-e43]

At week 24, the percentage of participants who achieved the primary outcome of ASAS20** was similar in both IBI303 and adalimumab arms, be it in the full analysis (75 percent vs 72 percent) or the per-protocol cohort (80 percent for both).

“[T]he primary outcome in [both] populations indicate therapeutic equivalence between the biosimilar candidate IBI303 and adalimumab,” said the researchers. “[Moreover,] clinical responses to IBI303 occurred as early as 2 weeks after treatment and the response was sustained through week 24, showing a pattern similar to that of adalimumab.”

Safety-wise, both the IBI303 and adalimumab arms had similar rates of treatment-emergent adverse events (AEs, 79 percent vs 82 percent), drug-related AEs (61 percent vs 64 percent), and serious AEs (3 percent vs 4 percent), signifying the manageable and acceptable safety profile of IBI303.

 

Bridging the gap

The high cost of adalimumab (>US$2,000/month) is a huge setback, as “[this] is well beyond the affordability of most Chinese patients, considering the cost is not covered by health insurance,” explained the researchers. [Zhonghua Yan Ke Za Zhi 2013;49:285-288]

To bridge the gap between the medical need and treatment affordability, the National Medical Products Administration of China had issued technical guidelines for the regulation of biosimilars in 2015, a key step to foster and facilitate the domestic development of biosimilars. [GaBI Journal 2018;7:75-76] The development of biosimilars may provide a tremendous benefit to the large fraction of patients with autoimmune and rheumatic diseases, whose medical needs are hampered by the steep prices of originator drugs, noted the researchers.

“We anticipate the incoming approval for biosimilars like IBI303, which will substantially improve patient access to treatments for autoimmune and rheumatic diseases … [T]he approval of IBI303 would greatly enhance accessibility to treatment for [our] large patient population … who cannot afford the high cost of adalimumab,” concluded the researchers.

 

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Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Elaine Soliven, 6 days ago
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.