European regulators on Friday set out broad guidelines for the approval of biosimilar antibody drugs, including lower hurdles than for new medicines and allowing the possibility of different diseases being addressed by the same copy antibody.
The long-awaited guidelines pave the way for cheaper copies of multi-billion-dollar medicines used to treat cancer and other serious diseases, although analysts said the requirements would still limit competition to a few well-funded companies.
The European Medicines Agency said drugmakers would have to establish that a generic was not inferior to the reference antibody — a lesser requirement than for a new non-generic drug, with deviations from guidelines warranted as long as they could be scientifically justified.
“The focus of the biosimilarity exercise is to demonstrate similar efficacy and safety compared to the reference product, not patient benefit per se, which has already been shown for the reference product,” it said.
One analyst, who did not want to be named, said drugmakers would still have to carry out clinical trials to establish similarity, and although they could circumvent some of the more extensive tests they would still have to do safety trials.
“The bottom line is this is all going to cost money and take time, which will limit it to the big players,” he said.
“Ultimately it is enabling a product to be approved on an abbreviated pathway on the basis it is similar to something that is already there, not the same.
“If you don’t have substitutability you can only have a fairly limited impact on products already established in the market.”
Analysts at Deutsche Bank also said the requirement for non-inferiority clinical trials limited competitors.
“While the documents should not surprise, they will likely remind investors that biosimilar antibody drugs are set to become a reality even if only a few companies have the capability to compete (the latter will limit the erosion to branded originator drugs),” they said in a note.
DISEASE EXTRAPOLATION
EMA said copy antibodies could be used for different diseases with adequate justification. However, when a reference antibody was licensed in two widely differing diseases, such as in rheumatoid arthritis and in cancer, extrapolations would be more “challenging.”
Up to now, complex biotech medicines have been generally immune from generic competition, unlike conventional pills and capsules. That is starting to change as patents expire and regulators work on ways to allow safe and effective copies.
Drawing up rules for copies of biotech drugs like antibodies is tricky because they are complex molecules grown in living cells that cannot be made absolutely identical to the original.
The guidelines will likely limit the field to a few well-funded companies such as Teva, which is working on biosimilars with Lonza, Novartis unit Sandoz and Hospira, which would be good news for original producers of monoclonal antibodies like Roche and Amgen.
Roche was the most exposed European company to potential biosimilar antibody competition, Deutsche Bank said, with patents on its key drugs Rituxan and breast-cancer treatment Herceptin due to expire in the next five years.
Rituxan, or MabThera, which loses patent protection in 2012, is mainly used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis, and had sales last year of 6.1 billion Swiss francs ($6.1 billion).
Teva is already running separate trials for its biosimilar version of Rituxan, pre-empting EMA’s view on approval in widely different indications.
The agency also said on Friday that the drugs that were authorized could be subject to more thorough monitoring than normal.
Worldwide sales of all biologic drugs reached $130 billion in 2009, according to IMS Health, and industry analysts believe the potential market for biosimilar copies could be worth tens of billions of dollars by the second half of the decade.
David Cowell
Reuters