J&J and EGA differ on safety impact of same INNs for biosimilars
The Janssen Pharmaceutical Companies of Johnson & Johnson, a research company owned by J&J, submitted a petition on Wednesday requesting the FDA “require biosimilars to bear non-proprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars.”
The firm’s request is out of step with Mylan, GPhA and Novartis, who since September have all come out in support of a shared international non-proprietary name (INN) for biosimilars and branded biologics.
The European Medicines Agency (EMA) and World Health Organisation (WHO) also support same name use for biosimilars.
‘Serious unintended consequences’
Johnson & Johnson chief biotechnology officer Jay Siegel said problems with biosimilars of Janssen’s anaemia drug Eprex/Erypo (epoetin alfa) in 2007 had raised “important considerations” surrounding naming.
In its petition, J&J said some patients taking Eprex/Erypo outside the US in the 2000s developed a serious condition, pure red cells aplasia (PRCA).
The culprit was found to be uncoated rubber syringe stoppers which released harmful organic compounds when exposed to the stabilizer polysorbate 80. In response, Johnson & Johnson changed the stopper material.
However, after the replacement, there were a “reported 15 cases of erythropoietin antibody-mediated PRCA in patients with chronic kidney disease who had been administered subcutaneous epoetin alfa” outside the US, J&J wrote.
“The Thai market included multiple epoetin alfa products and hospitals and pharmacists frequently switched patients among them, often with incomplete documentation.”
The company said it had been unable to determine which version of the drug had been given to the affected Thai patients and the event raised concerns over pharmacovigilance.
In the Eprex case, changes to the finished form of the drug had caused the dangerous reaction, not a modification of cell lines or active ingredients, said J&J.
“For any biologic, companies and regulators cannot eliminate the possibility that a seemingly innocuous manufacturing change may have serious, unintended clinical consequences,” the petition continued.
EGA: ‘confusion’ risk
In a contrasting stance, the European Generics Association (EGA) told BioPharma-Reporter.com different names for biosimilars would hinder traceability.
“Different INNs are very likely to increase confusion,” said Suzette Kox, senior director, Scientific Affairs, EGA.
In Europe, biosimilars share an INN with patented originals. To date, the European Medicines Agency has approved 16 biosimilars, the most recent being Grastofil (filgrastim) for the treatment of Neutropenia.
“It is important to remind that the INN only identifies the active substance not the finished drug product,” said Kox. “It was never intended to be a unique tool for traceability; this has been fully recognized by the EU regulators.
“Indeed the EU pharmacovigilance legislation requires the approved name of the medicine - and the batch number – to be reported in case of adverse reactions.”
‘Safety’ motivation
J&J is the world’s sixth-largest biologics company, with a portfolio of original biopharmaceuticals including Orthoclone OKT3 (Muromonab-CD3), the first approved monoclonal antibody; Proctir (epoetin alfa); and Remicade (infliximab).
BioPharma-Reporter.com asked the company if its stance on biosimilar naming was linked to the prospect of losing market share over its own innovative biologics.
Mark Wolfe, senior communications executive at Johnson & Johnson, answered the firm supported “appropriate standards for biosimilars that are in the best interest of patient safety.
“Our purpose in submitting the Citizen Petition was to ensure our insights in distinguishable naming are heard.”
No biosimilars have yet been approved in the US, but legislation has already been made regulating their future use.
In August 2013, California passed Senate Bill 598, which allows doctors to refuse to prescribe biosimilars in favour of branded drugs. In addition, pharmacists are required to alert physicians when a biosimilar is dispensed instead of the reference product.
