Archive for month: May, 2024

“With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. “Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings.”

The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since July 2023.

“The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn’s disease and ulcerative colitis, which affect nearly 1 in 100 Americans,” said Michael Osso, President & CEO of the Crohn’s & Colitis Foundation. “The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines.”

“This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, President & CEO of the Arthritis Foundation. “We stand united with our patients and healthcare providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger healthcare ecosystem.”

“Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis,” said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. “We welcome the introduction of this additional formulation to expand the array of options available to our community.”

The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.

Dr G. R. Ravindranath, general secretary of the Doctor’s Association for Social Equality criticized
Ramdev for falsely claiming that Coronil could cure and prevent COVID-19. Dr Ravindranath accused Ramdev of publishing false advertisements and deceiving
the public with unverified medical claims.

Representatives of the Doctors Association for Social Equality argued
that Ramdev’s promotion of Ayurvedic medicines contradicts modern scientific
principles. They demanded strict measures against Ramdev for misleading people
under the pretence of promoting Ayurveda. 

Citing Patanjali products as an example, the doctors advocate for a ban
on advertising pharmaceutical products without scientific evidence to support
their use. They insist that policies must be implemented to combat fake
science, superstitions, and anti-scientific notions in medicine, as these can
negatively affect individuals’ health and well-being across the country, reports DT Next. 

The association stated, “We demand that the Union Government should apologize to act in favor of advertising such medicines. There should be stringent action against promoting medicines that can be harmful for the patients. The government needs to come up with policies on regulating mixopathy, Vedic medicine, traditional medicine, spiritual therapies and others, being practiced for treating diseases.”

Recently, a report in Reuters stated that a state regulator in India has suspended the manufacturing licenses of 14 products produced by pharmaceutical companies associated with the country’s renowned yoga guru. The suspension comes in response to the repeated dissemination of misleading advertisements regarding the efficacy of the products, as indicated by a government order. 

The Supreme Court of India has in recent weeks repeatedly criticized Ramdev for not complying with its directives in an ongoing lawsuit to stop misleading advertisements of some of his traditional ayurvedic medicines. Though the company has already apologized for the unscientific advertisement, the Supreme Court asked whether the apology published by Patanjali Ayurved was as big as the advertisements.