Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…
INSIGHTS+
The third quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include CVS Health acquired Signify Health for ~$8B, Amgen acquired Chemocentryx for ~$4B
The third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo,…
INTRODUCTION
Duchenne Muscular Dystrophy (DMD) is a rare and the most frequent genetic neuromuscular disorder affecting all races and ethnicities (affecting approximately 1 in 3,500 population). It is characterized by progressive muscle weakness and some specific abnormalities like changes in muscle fiber size, scar tissue formation, muscle fiber necrosis, and inflammation evidenced from muscle biopsy…
The EMA approved 5 New Chemical Entity (NCE) and 4 Biologic Drugs in August 2022, leading to treatments for patients and advances in the healthcare industry
In August 2022, the major highlights drugs were Lynparza’s approval for breast cancer, Imbruvica (ibrutinib) for chronic lymphocytic leukaemia, Sunlenca (lenacapavir) for HIV Infection
PharmaShots has compiled a list…
Active Ingredient: Aflibercept
Strength: 2 mg (0.05 mL)
Dosage Form: Injection (intravitreal)
Mechanism of Action: VEGF-A and PlGF inhibitors
First Approval: US (18 Nov 2011), EU (27 Nov 2012)
Revenue1
EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…
The US FDA approved 4 NDAs and 1 BLA in August 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 47 novel products in 2022
In August 2022, the major highlights drugs were Calquence's approval for blood cancer, Imbruvica (ibrutinib) for chronic graft versus host disease in…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of August, Formycon reported P-III (VESPUCCI) trial results of…
Gastroparesis is a chronic disease affecting the motility of the stomach muscles. It refers to partial paralysis of the stomach. It usually occurs due to nerve injury including vagus nerve damage. Normally the strong muscular contractions of vagus nerve move the food through the digestive tract, but in the case of gastroparesis, this spontaneous movement…
Active Ingredients: Ustekinumab
Strength: 45 mg/0.5 mL or 90 mg/mL (SC), 130 mg/26 mL (IV)
Dosage Form: Injection
Mechanism of Action: Interleukin 12 & 23 inhibitor
First Approval: US (25 Sep, 2009), EU (16 Jan, 2009)
Revenue1
Stelara is the leading blockbuster drug of Johnson & Johnson. Stelara contributed 9.7% of the Company's total revenues for 2021. Stelara up took…
The US FDA approved 4 NDAs and 1 BLA in July 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 42 novel products in 2022
In July 2022, the major highlights drugs were Zonisade's approval for partial seizures in adults and pediatric patients with epilepsy, Opzelura (ruxolitinib)…

