Page 152 - CW E-Magazine (22-4-2025)

Pharmaceuticals

PATENT FIGHT

US appeals court clears Sun Pharma’s alopecia drug

launch

Sun Pharmaceuticals Industries said nary injunction is no longer in effect,” the Sun Pharma had acquired Leqselvi
the US Court of Appeals for the Fede- company’s stock exchange fi ling said. through its Concert Pharma buyout in
ral Circuit has ruled in favour of the March 2023. The deal gave Sun Pharma
company and vacated its preliminary Leqselvi is used to treat alopecia rights to Concert Pharma’s lead candi-
injunction of delaying the launch of its areata, an auto-immune condition that date deuruxolitinib.
alopecia drug ‘Leqselvi’ (deuruxolitinib), causes hair-loss, and it affects almost
effective immediately, after almost a 2.5 percent of the US population. Sun Incyte Corporation had fi led a patent
year of legal battle over its patent. Pharma has a fi ve-year marketing infringement suit against Sun Pharma,
exclusivity for the product. which claimed that the drug is an
“On April 9, 2025, the US Court of infringement on one of its patents for
Appeals for the Federal Circuit held an Sun Pharma said it will disclose its ruxolitinib. Incyte claimed that the
oral argument on the company’s appeal launch plans in due course of time. patent was valid until December 2026,
of the US District Court for the District and following that US District Court of
of New Jersey’s decision that previously According to market estimates, Leq- New Jersey had granted a preliminary
granted a preliminary injunction. While selvi is projected to contribute $90-mn to injunction to Incyte in November last
the litigation between Incyte Corporation Sun Pharma’s sales in the fi nancial year year. This prevented Sun Pharma from
and the company continues, the prelimi- 2026 (FY26), and $125-mn in FY27. rolling out Leqselvi in the US.
MONOCLONAL ANTIBODY
Biocon Biologics gets USFDA approval for cancer drug

Biocon Biologics, the biosimilar arm The drug is administered through and a strong addition to our oncology
of Biocon, has expanded its oncology intravenous infusion. With this approval, portfolio,” said Mr. Shreehas Tambe,
portfolio with the USFDA approval of ‘Jobevne’ becomes the company’s fourth CEO & Managing Director of Biocon
‘Jobevne’, a cancer treatment drug. oncology biosimilar in the US, adding to Biologics.
its existing portfolio that includes Ogivri
‘Jobevne’ is a biosimilar version of (trastuzumab), Fulphila (pegfi lgrastim), The US market contributes 40 per
Bevacizumab (marketed as Avastin), a and Abevmy (another bevacizumab cent to Biocon Biologics’ overall reve-
monoclonal antibody used in combina- biosimilar approved in other markets). nue. The company currently has 20 bio-
tion with chemotherapy to treat several Bevacizumab sales in the US stood at similars in its development pipeline,
types of cancer, including colorectal, around $2-bn in 2023. “Jobevne is our including insulins and monoclonal anti-
lung, brain, kidney, and cervical cancers. seventh biosimilar approved in the US bodies across various therapies.

Shilpa’s Raichur unit passes second consecutive

USFDA inspection
Shilpa Medicare has announced that clean inspection at the facility, with solid dose drug substance produc-
its wholly owned subsidiary, Shilpa the USFDA conducting the audit from tion. The successful USFDA inspec-
Pharma Lifesciences, has successfully March 10-14. Operational since March tion ensures that the site will continue
passed a US Food and Drug Administra- 2008, the 22-acre facility is the compa- to support the commercial supply of
tion (FDA) inspection of its Unit-2 faci- ny’s second and largest API manufac- oncological actives for US patients, the
lity in Raichur (Karnataka), with no 483 turing site. It forms part of a broader company said. The Unit-2 has capacity
observations. network of seven facilities that encom- for 520-KL and supports more than 250
pass biologic substance manufacturing, customers across 25 APIs and part of
This marks the second consecutive fi ll-fi nish capabilities, and large-scale CDMO offerings.

152 Chemical Weekly April 22, 2025

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