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Pharmaceuticals Pharmaceuticals

‘INADVERTENT’ OMISSION DRUG DEVELOPMENT
Bharat Biotech credited ICMR, NIV as Covaxin Lupin completes phase-III global trial on biosimilar

co-inventors after missing them initially: Govt. of Lucentis

Union health minister Mr. J. P. raised, the minister said, the application Lupin has completed advanced clini- and the European Medicines Agency in patients with Neovascular Age-
Nadda said that Bharat Biotech initially was corrected. cal trials (Phase III) of its biosimilar (EMA). related Macular Degeneration, Lupin
did not mention Indian Council of version of Roche’s Lucentis (ranibi- said.
Medical Research (ICMR), National Mr. Nadda said that it was informed zumab), used to treat age-related macu- “The study has achieved its primary
Institute of Virology (NIV) as co-in- by Bharat Biotech that the inclusion of lar degeneration (AMD). endpoint of therapeutic equivalence The global phase 3 study marks an-
ventors in the patent application for ICMR-NIV was inadvertently missed in visual acuity improvement for wet other signifi cant developmental mile-
Covaxin and the application was cor- and it has now fi led a correction in the About 600 patients from India, the AMD patients, showcasing comparable stone for Lupin’s Lucentis biosimilar,
rected after objections were raised by patent offi ce. US, the European Union and Russia safety and immunogenicity between said Mr. Cyrus Karkaria, President,
the government. company for not mentioning the names were on the study, and received LUBT010 and Lucentis,” a note from Lupin Biotech. “We will be fi ling mar-
of ICMR and NIV in the patent appli- There were two parts to the deve- either Lupin’s candidate ‘LUBT010’ or Lupin said. keting applications for ‘LUBT010’ in
Covaxin, which was widely used as cation, Mr. Nadda gave a detailed reply. lopment of Covaxin. The fi rst was to Lucentis 0.5 mg, as an injection once all major global markets this year,” he
a COVID vaccine, was jointly developed isolate the virus, study the challenges and a month for 12 months. Patients were It markets the ranibizumab biosimi- added.
by ICMR, NIV and Bharat Biotech There was a joint Memorandum of related issues, and these were done by followed for efficacy, safety and lar in India under the brand name
International Ltd. Understanding (MoU) between ICMR, ICMR and NIV. Then, the development immunogenicity assessment, Lupin said, RaniEyes, since 2022. The global study Mr. Nilesh Gupta, Lupin Managing
NIV and Bharat Biotech for the deve- of the vaccine was done by Bharat Bio- adding that the data from this study was in line with recommendations Director said, “We have already com-
Mr. Nadda, speaking during the lopment of Covaxin, he said. Initially, tech, which spent around Rs. 60-crore would be part of Lupin’s applica- from the EMA and USFDA, to evalu- mercialised four products to date and
Question Hour in the Lok Sabha, also when Bharat Biotech fi led the patent to that end, Mr. Nadda revealed. The tion for marketing approval with the ate the effi cacy, safety, and immunoge- there are several more at various stages
said that ICMR has received around application, it bore only its name in the ICMR spent around Rs. 35-crore to- US Food and Drug Administration nicity of ‘LUBT010’ versus Lucentis of clinical trials.”
Rs. 172-crore as royalty for Covaxin from application. As soon as the government wards the development of Covaxin,
Bharat Biotech. Responding to Trina- and ICMR came to know about it, “we including Rs. 20-crore towards phase Gland Pharma’s Hyderabad unit gets three observa-
mool Congress member Sougata Roy, questioned them” as the co-ownership, 3 clinical trial which involved funding
who had asked whether the government co-inventor names were not there, Mr. of 25 sites for screening and recruiting tions post USFDA inspection
took any punitive action against the Nadda said. After the objection was 25,800 participants.

POLICY TWEAK The United States Food and Drug ducted an un-announced inspection of The observations issued are neither
DCGI to accept toxicity data approved in other Administration (USFDA) has issued the company’s Pashamylaram facility repeated observations nor related to data
three observations to Gland Pharma for at Hyderabad for Good Manufacturing integrity,” the company said. The cor-
countries for drug review its Hyderabad facility. Practices (GMP) between July 25, 2024 rective and preventive actions for these
and August 02, 2024. “The inspection observations will be submitted to the
In an exchange fi ling, Gland Pharma was concluded with three 483 observa- USFDA within the stipulated period, it
In a move that could accelerate the such data has been gene- logical products and
availability of medicines in the country, rated. This won’t, however, Investigational New Drugs informed that the USFDA had con- tions, which are procedural in nature. added.
India’s drug regulatory authority has be applicable for biological (INDs). Nestle India invests over Rs. 700-crore in jv with
reportedly decided to recognise pre- and investigational new
clinical toxicity data already generated drugs, the regulator said. As per the New Drugs Dr. Reddy’s
and accepted by regulatory authorities It said also that the use of and Clinical Trials Rules,
of other countries for reviewing new unapproved excipients in 2019, the regulator noted
drugs, subsequent drugs and fi xed-dose formulations will require that a repeated dose toxi- Nestlé India said it has invested medical nutrition, specialised nutrition, for the slump sale of its existing medical
combinations (FDCs). relevant safety data. city study in India may not be mandatory Rs. 705.6-crore in the joint venture with nutraceuticals, vitamins, minerals, herb- nutrition and nutraceuticals (NHSc)
in certain cases, including when data on Dr. Reddy’s Laboratories Ltd., which als and supplements. Nestle India will business to the jv company, at a lump-
Animal toxicity data generated in A recent circular by the Drugs Con- animal toxicity as per the specifi cations has been established to operate in the own 49 percent equity in the jv while sum consideration of Rs. 218.90 crore.
other nations is likely to be accepted, troller General (India) (DCGI) says in the rule has been submitted and the nutritional health solutions space. Dr. Reddy’s Labs will own 51 percent
and the regulator may not seek fresh the Central Drugs Standard Control same has been considered by the regula- share. Meanwhile, Dr. Reddy’s Laborato-
tests in India on a case-to-case basis Organisation (CDSCO) has reviewed the tory authority of the country which had As per a stock market fi ling from ries said that it has made an investment
depending upon the quality of data and requirement of toxicity studies for new approved the drug previously, the regu- Nestlé India, the jv will offer a range The company added that it has exe- of Rs. 734.3-crore in the jv Company
the credentials of the laboratory where drugs, SNDs and FDCs, excluding bio- lator said in the circular. of products in categories including cuted a Business Transfer Agreement formed with Nestle India.

158 Chemical Weekly August 13, 2024 Chemical Weekly August 13, 2024 159

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