Page 151 - CW E-Magazine (17-10-2023)

Pharmaceuticals Pharmaceuticals

EXPANDING PRESENCE HELPING POOR PATIENTS

Cytiva opens new facility and experience centre in Generic companies need to improve access

Pune strategies in LMICs: Report

Cytiva, the biopharma fi rm belong- According to Cytiva’s 2023 Generic drugmakers may have been prove access and tailor products for
ing to the American conglomerate ‘Global Biopharma Resilience In- lauded for making drugs affordable, the intended patients, she pointed to
Danaher Corporation, which also includes dex’, 65% of biopharma executives across the world. But it is not time to “adaptive research” – where products
Pall Life Sciences, has announced the in India say that the manufacturing rest on laurels of the past, and they now are designed for paediatric consump-
opening of a new 33,000-ft2 manufac- of biologics in their country is likely need to work on improving access to tion; or with simpler dosing regimens,
turing facility in Pune. The new facility to dramatically increase over the next their medicines, said a report from the or heat-stable features (not requiring
will manufacture Cytiva’s bioprocess- three years. This is 15% higher than Netherlands-based Access to Medicine refrigeration), for example. “Generic
ing equipment including tangential the global average, and in line with Foundation. companies get involved way too
fl ow, virus fi ltration, and inactivation in Asia-Pacifi c and long-term growth India’s ‘National Biopharma Mission’ late in a product to be able to serve
systems. strategy. We must also play a key role to make India a hub for the develop- The inaugural report from the cer of the Foundation. Some compa- patients,” she said, urging them to get
in developing and nurturing the talent ment of novel and affordable vaccines Foundation’s generics and biosimilars nies did participate in the tendering involved at the design stage to improve
The facility will also be home to needed to meet the demand for biologic and biologics. programme analysed five major systems, but patients still pay out-of- access measures.
the ‘Cytiva Experience Centre’ which medicines. Our Cytiva Experience Cen- generic companies – Cipla, Hikma, Sun pocket in several countries and tend
will provide immersive training pro- tre will provide the ongoing learning Additionally, 46% of biopharma Pharma, Teva and Viatris – on efforts to to get left out, she said, calling for Given their signifi cance, the report
grammes for upstream and downstream and development needed to accelerate executives in India say that they are expand access to their products in low- systems to track if patients did indeed suggests, generic companies can also
technologies as well as digital and au- the development of novel therapeutics focusing on onshoring drug manufac- and middle-income countries (LMICs). get the medicines. help bolster manufacturing in LMICs,
tomation software. Additionally, custo- and help India deliver on its Aatmanir- turing or increasing domestic sourcing The companies were chosen for their and ensure products got closer to
mers will have greater access to thought bhar Bharat vision and mission.” over the next 12 months to boost supply size, infl uence and involvement in Though generic companies had a patients. Companies could work with
leadership events and to demonstra- chain resilience. However, 20% of exe- global health, the report said. large regulatory footprint in LMICs, local partners on production and help
tions of Cytiva’s products, such as Located at Hinjawadi Rajiv Gandhi cutives say that access to new equip- often companies did not register medi- build buffers for a constant supply,
ÄKTA, Allegro, iCELLis and Sepax. Infotech Park, this new facility comple- ment has become worse over the last Generic companies need to out- cines in several markets, for reasons said Ms. Iyer, countering the view in
Commenting on the new facility, ments Cytiva’s existing facilities in two years, indicating a need to improve line access strategies to ensure their including the expense involved or the some sections of industry that regio-
Mr. Rajan Sankaran, Commercial General Bengaluru which include a Fast Trak Centre, local access to equipment so that medicines reach the people who need it, paying ability in the region, she said. nalisation would erode the benefi ts of
Manager, India, Cytiva, said, “Forti- and a centre for research and develop- Indian companies can deliver afford- across several regions, said Ms. exporting from a low-cost manufactur-
fying our manufacturing footprint in ment across bioprocess, discovery, medi- able life-changing therapeutics domes- Jayasree Iyer, Chief Executive Offi - Outlining other measures to im- ing base.
India is critical to Cytiva’s operations cal, and genomic medicine businesses. tically and to the region.
QUALITY ISSUES
AFFORDABLE MEDICINES
Sun Pharma, Aurobindo recall drugs from US market
BDR launches generic drug for fungal infections
Drug fi rms – Sun Pharmaceutical Inc. is recalling the product for being Jersey-based Aurobindo Pharma USA
BDR Pharmaceutical has launched by us, is a revolutionary product, Industries and Aurobindo Pharma – are ‘subpotent’, USFDA stated. The Inc., a unit of the Hyderabad-based drug
generic antifungal drug Zisavel available at 1/3rd of the innovator recalling products from the US market company initiated the nationwide (US) major, is recalling the affected lot due
(isavuconazole) for the treatment of brand price. Isavuconazole will play due to manufacturing issues, according Class III recall on September 7 this to “failed dissolution specifi cations”,
infections like invasive aspergillosis an important role in controlling the to the US Food & Drug Administration year. As per the USFDA, a Class III re- the USFDA noted.
and mucormycosis. infection and overall life expectancy.” (FDA). call is initiated in a “situation in which
use of, or exposure to, a violative pro- The company initiated the Class II
The drug is priced at one-third The aim is to “reduce the cost of As per the latest Enforcement Report duct is not likely to cause adverse recall in the US on August 2 this year.
the cost of present therapies avail- therapy for invasive fungal diseases issued by the American health regulator, health consequences”. As per the USFDA, a class II recall
able from the innovators, a BDR Director (Business Development), with isavuconazole to be on par a US-based subsidiary of Sun Pharma is initiated in a situation in which use
note said. Part of the azole antifun- said, “The burden of fungus diseases with voriconazole and posaconazole is recalling 69,707 cartons of Cequa The US health regulator stated that of, or exposure to, a violative product
gal class of medication, isavuco- varies substantially based on geogra- (new-generation anti-fungal agents), (cyclosporine ophthalmic solution) from Aurobindo Pharma is recalling 9,890 may cause temporary or medically
nazole is used to treat invasive asper- phy, type of infection, severity of the making it more accessible to patients the US market. The medication is used bottles of Rasagiline tablets, a medi- reversible adverse health consequences
gillosis (caused by a type of fungus), disease, and various other socioeco- who are unable to afford it currently,” for the treatment of dry eyes. New Jersey- cation indicated for the treatment of or where the probability of serious ad-
it said. Mr. Raheel Shah, BDR Group nomic factors. This drug, developed BDR said. based Sun Pharmaceutical Industries Parkinson’s disease, from the US. New verse health consequences is remote.

150 Chemical Weekly October 17, 2023 Chemical Weekly October 17, 2023 151

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