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Australia approves first mAb biosimilar

The government estimates that increased use of biosimilar medicines will deliver $880 million in PBS savings over the next 5 years.

Inflectra, the first monoclonal antibody (mAb) biosimilar therapy, has been approved in Australia, according to Hospira.

The Therapeutic Goods Adminstration's approval of Inflectra is based on extensive data, including the results of pivotal trials in patients which concluded that the biosimilar was therapeutically comparable to Remicade.

It has been registered for the treatment of eight inflammatory conditions: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn's disease, refractory fistulising Crohn's disease, adult and paediatriculcerative colitis, and plaque psoriasis.

Inflectra is a biosimilar medicine formulated to deliver comparable efficacy, safety and quality as the originator biologic, Remicade β€“ a mAb therapy that cost the PBS more than $100 million last year.

The Federal Government in Australia estimates that increased use of biosimilar medicines will deliver $880 million in Pharmaceutical Benefits Scheme savings over the next five years, according to the press release announcing the drug's approval.

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