Drug Approval | April 20, 2023
Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)
Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions
To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
Lupin’s subsidiary in Philippines, Multicare Pharmaceuticals, will file for marketing approval and be responsible for distribution and commercialization of the biosimilars once approved.
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
The proposed transaction involves the sale of the global biosimilars portfolio of Viatris to Biocon Biologics
ICICI Direct expects revenue CAGR of 35.6% over FY22-FY24E mainly due to the consolidation of Viatris business and they expect EBITDA margin expansion of 230bps and earnings CAGR of 64.8% over FY22-FY24E
Aflibercept is the second biosimilar product that has entered the clinical trial phase after biosimilar Adalimumab
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