Rejected biosimilars: the Biferonex case

Biosimilars/Research | Posted 30/07/2009 post-comment0 Post your comment

On 19 February 2009, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommended refusal of the marketing authorisation for the medicinal product Biferonex intended for the treatment of relapsing remitting multiple sclerosis. The company that applied for authorisation was BioPartners GmbH.

Biferonex is a formulation of recombinant interferon beta-1a glycoprotein expressed by Chinese hamster ovary (CHO) cells transformed with the human interferon beta-1a gene. The amino acid sequence is identical to that of human fibroblast-derived interferon beta-1a and “rather bio(similar)” to other interferon beta-1a products, such as Avonex and Rebif.

 

However, unlike other similar products, Biferonex is formulated without human serum albumin (Albumin, Human) and is pH-neutral. These aspects are expected to make it less prone to inducing interferon beta-neutralising antibodies, which can limit the effectiveness of treatment. The interferon beta-1a in Bioferonex is (bio)similar, if not identical, to interferon beta-1a originally developed by Bioferon, a prior joint venture of Biogen Corporation, now Biogen Idec, and Rentschler Arzneimittel GmbH & Co.

 

The effects of Biferonex were first tested in experimental models before being studied in humans. BioPartners presented the results of one main study, in which Biferonex was compared with placebo in 339 adults with relapsing-remitting multiple sclerosis. Each patient received either Biferonex or placebo for two years. The main measure of effectiveness was the reduction in the number of attacks. The company also used information relating to Avonex, and from the published literature on medicines containing interferon beta.

 

The Committee noted that there were differences between the active substance in Biferonex and other interferon beta-containing medicines available on the market. It therefore concluded that the use of published studies of these interferon beta-containing medicines to support the use of Biferonex was not justified and that studies on Biferonex itself were required. The CHMP was also of the opinion that the results of the clinical study of Biferonex did not show enough evidence that the medicine was effective.

 

At that point in time, the CHMP was of the opinion that the benefits of Biferonex in the treatment of patients with relapsing-remitting multiple sclerosis did not outweigh its risks and recommended that Biferonex be refused marketing authorisation. BioPartners informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Biferonex, but that it will request a re-assessment and still wants to accomplish the registration of Biferonex.

Source: EMEA, Biopharma, BioPartners, Scrip

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