There appears to be a setback for Biocon as its biosimilars program hits a roadblock in Europe -- the drug products unit inspection done in March has not received the Good Manufacturing Practices (GMP) certificate by the French regulator.
In an interview to CNBC-TV18, Kiran Mazumdar Shaw, CMD of Biocon spoke about the latest happenings in the company.
"The French regulatory authorities inspected us in March this year and the scope of the inspection was to cover two drug substance facilities and two drug product facilities," said Mazumdar Shaw.
Below is the verbatim transcript if the interview:
Latha: How serious are the observations. When will you be ready for the next inspection and therefore does the EU permission get postponed?
A: Let me try and explain this to you and put it in the right context so that it provides a better clarity on this inspection report.
To begin with, the French regulatory authorities inspected us in March this year and the scope of the inspection was to cover two drug substance facilities and two drug product facilities. These drug substance facilities were the facilities that manufacture Pegfilgrastim and Trastuzumab.
The two drug product facilities - 1) is a multiproduct facility that actually manufactures Trastuzumab and Pegfilgrastim and 2) is a device assembly facility that produces our Insulin Glargine Pens.
Let me now go on to say that as far as the inspection is concerned, we had several observations in the drug substance facilities and the drug product facility but not in the device facility. I want to mention here that we had no observations in the device facility that produces Glargine Pens. Now we are required to provide a corrective action, preventive action (CAPA) plan after we receive the observations from any regulatory authority. These corrective actions or CAPA plans were provided to the French regulatory authority.
We have now received a GMP approval for both our drug substance facilities which is the Trastuzumab and Pegfilgrastim drug substance facilities and this is a very important GMP approval because this is the heart of the biosimilar programme. Bio manufacturing or biologics is a very complex process and it requires robust quality systems which endorses that we have very robust quality systems.
When it comes to the drug product facilities, they have said that we will give you the GMP based on a re-inspection and the remedial measures that they have sought, we believe are very expeditiously addressable and we believe that we can seek re-inspection at an early date. So as per our understanding we do not believe that it will have a material impact on our commercialisation timeline.
Anuj: Is the date finalised and what the nature of these observations. Is there data integration?
A: There are no data integrity issues at all. I must confirm that and I must categorically say there are no data integrity issues. They have listed a bunch of inspections or observations in their report which is on the public domain and if you look at these, most of them have been addressed and complied with some of them is what we need to do these remedial measures for and that is what we will address expeditiously and I am very confident that we will be able to seek a re-inspection at an early date. What is that date. I cannot tell you because we are yet to complete the remedial measures and then we will ask them for an early re-inspection. So be a bit patient because this has just happened and as far as I am concerned yes, this re-inspection is first for Biocon but it is no unusual.
Anuj: It does no impact your US filing and US Food and Drug Administration (US FDA) approvals?
A: Basically all regulatory authorities have different inspection and they take their own decisions. So I do not wish to comment on these kinds of issues.
Reema: Going ahead what is the status of filings of biosimilars in the US and even going ahead from the United States. When can we expect an approval?
A: As far as our filings are concerned, we have shared with you that as far as EU is concerned you have these three products - Trastuzumab, Pegfilgrastim and Insulin Glargine are under review and this is what we are talking about for this inspection.
As far as US is concerned, we have also filed both Trastuzumab and Pegfilgrastim, which are under review and both these products have got a target action date; one is in September and other in October this year. So that is as far as I can share.
All I would say is yes; we are addressing these corrective actions very expeditiously. We are well underway and we hope that we can ask for re-inspection at an early date.
Latha: You wouldn't worry about the Japanese drug regulator, will you? There you have already got an approval?
A: Yes but as I mentioned there was no observation even from European Medicines Agency (EMA) from the fresh regulatory opportunities on our devices facility although it was a part of the scope, so they have to mention the product but as far as we are concerned, they have inspected the Glargine device facility and there were zero observations. So that also I want to emphasize here but this is a clarity that I would like to provide.
Anuj: From your side, by when will you be ready for a re-inspection?
A: I cannot tell you right now but as I said, we will try and ask for a re-inspection as soon as possible.
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