Page 152 - CW E-Magazine (20-5-2025)

Pharmaceuticals Pharmaceuticals

FUTURE PLANS India has long enjoyed a cost advan- measures, and higher fees for foreign Indian pharma fi rms, although producing
Biocon plans $150-mn capex in two years tage in manufacturing drugs, particu- manufacturers. many formulations domestically, rely
larly generics. Many Indian companies
heavily on Chinese imports for APIs.
export medicines to the US, benefi ting The report said “while Indian com- This could put them under further
Biopharmaceutical fi rm Biocon each in FY25. It plans to launch onco- from lower operational costs. Howev- panies have remained silent due to the scrutiny in the US market and hurt their
plans to invest $150-mn in capital ex- logy drug bevacizumab in the US in the er, the Trump administration’s orders cost arbitrage off ered by manufacturing in business prospects.
penditure over the next couple of years, fi rst half of this year when it also ex- now push US agencies to bring back India. The new order, if implemented,
with $100-mn earmarked for its biolo- pects approval for diabetes drug insulin (re-shore) drug manufacturing – including may have the potential to restructure The orders are also aligned with
gics division and the remaining for the aspart, according to Mr. Matthew Erick, APIs (Active Pharmaceutical Ingre- the US generic supply chain as it directs the administration’s broader focus on
generics business. A large part of the bio- Chief Commercial Offi cer – advanced dients), KSMs (Key Starting Materials), high level eff orts for the US agencies national biosecurity. One of the two
logics investment “will go to enhance markets at Biocon Biologics. “We have and raw materials – into the US itself. to re-shore manufacturing back to orders also limits funding for research
the capacities in Malaysia,” Mr. Kedar an incredible oncology portfolio and it the US”. linked to increasing virus pathogenicity,
Upadhye, Chief Financial Offi cer of will be a nice addition to our portfolio As per report, this shift poses a citing potential biosecurity threats.
Biocon Biologics, told analysts in an and we will be well positioned with direct threat to Indian drug makers, as If these measures are fully enforced,
earnings call. Capex in biologics is bolstered by strong growth in gener- our sales force,” he said. It has already it could reduce the cost arbitrage they they could raise operational costs for Overall, while the full fi nancial and
expected to get moderated after a cou- ics, steady progress in biosimilars and launched yesintek (biosimilar Usteki- have enjoyed so far. Indian companies and weaken their operational impact will unfold over
ple of years, he said. ongoing traction in research services,” numab), one of the fi rst biosimilars to competitive edge. time, the Trump administration’s push
Dr. Kiran Mazumdar-Shaw, Chairperson, Stelara in the US. In addition, Trump’s directive in- for domestic drug manufacturing marks
Mr. Siddharth Mittal, Managing Biocon Group, said at the analyst call. cludes faster regulatory clearances for Another major concern is the likely a clear policy shift that could signi-
Director and CEO of Biocon, said, “For During the quarter, the company’s US-based plants, increased inspections mandate to disclose the source of fi cantly alter the global pharmaceutical
generics, we will be looking at $50-mn During the quarter, Biocon launched arm Syngene expanded its biologics of foreign facilities, stricter compliance APIs used in drug manufacturing. supply chain, the report stated.
capex next year and with that, majo- lenalidomide – a medication used to manufacturing footprint through an
rity of our ongoing capex programmes treat types of multiple myeloma – and acquisition of a facility in the US. DRAFT RULES
will come to an end and there will be oncology drug dasatinib in the US, and CDSCO seeks comments on biosimilars guidelines
a small bit of maintenance capex going anti-diabetes medication liraglutide in The company is also looking at
forward.” In its fourth quarter result, the UK. One of the primary focus areas raising Rs. 4,500-crore through a com- The Central Drugs Standard Control makers. This is the second comprehensive
Biocon had reported a 153% surge in for the company going ahead will be bination of QIP and private placement. Organisation (CDSCO) has released a overhaul of guidelines for biosimilars
net profi t to Rs. 344-crore, while con- its peptide portfolios, especially GLP1s The proceeds of the funds raised will draft of the revised Guidelines that was fi rst released in 2012 and
solidated total revenue for Q4 was which it sees as the key driver of future be primarily used to meet fi nancial on Similar Biologics (Biosimilars) revised in 2016.
Rs. 4,454-crore, a growth of 12% the growth. The company is also betting obligations towards commitments and put regulatory requirements for marketing
previous year. big on its biosimilars that continued to options from the structured debt that authorisation in India, 2025, for public In India, biosimilars is an emerging
build shares in global markets with four the company has from investments in consultation and sought feedback from segment with sales reaching close to
“This quarter’s performance was biosimilars recording sales of $200-mn its biologics unit. stakeholders with an aim to update $867-million in 2024 and expected to
the current guidelines to refl ect recent grow at around 17% annually, accord-
POLICY IMPACT international guidelines. The stake- guidelines in line with recent inter- ing to industry estimates. New gene-
New US executive orders may hit Indian pharma holders have been asked to share their national guidelines,” the drug regulator ration injectable drugs for a range of
comments within 30 days.
said in a notice. Once fi nalised there cancers or autoimmune diseases have
exports, reshape global drug supply chains: Report will be minimal scope for change in the seen several biosimilars in the Indian
Earlier a committee comprising of document, it further said. “Therefore, market and are becoming the mainstay
The recent executive orders on implemented strictly. The technical subject experts, representa- all interested stakeholders are reques- for medical treatment.
pharma issued by President Donald report said, “The new tives from National Institute of Biolo- ted to provide comments/suggestions
Trump are expected to create signifi cant development, if fully gicals (NIB), Department of Biotechno- within the window of 30 days,” the The revised guidelines on biosimi-
challenges for Indian pharmaceutical implemented, can dis- logy (DBT) and representatives from notice dated May 6 further said. lars are mostly aligned with regulations
companies, especially those operating rupt and reshape global industries involved in manufacturing of followed by global regulatory bodies.
in the US generic drug market, accord- pharma supply chains. similar biologics was constituted. The revised set of regulations aims Importantly, the draft calls for “mini-
ing to a report by Nuvama Research. Over the past few months, at setting stringent quality standards for mising the use of animals in testing,”
we have been observing “The committee meetings were research and manufacture of biosim- but subject to several conditions. “The
These policy moves aim to priori- announcement of the convened to discuss the revisions in ilar drugs. Biosimilar are medicines 3Rs principles for animal experiments
tise domestic manufacturing of pharma- cumulative $15-bn capex the guidelines. In view of advances in based on living cells and are near iden- (Replace, Reduce, Refine) should
ceuticals in the United States and could plans in the US by innova- scientifi c knowledge and experience, tical copies of originally invented bio- always be followed to minimise the use
reshape global drug supply chains if tive pharma companies”. it was decided to revise the existing technology drugs sold by global drug of animals in testing,” the draft said.

152 Chemical Weekly May 20, 2025 Chemical Weekly May 20, 2025 153

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