2019 Biosimilars Dosage 
European Pharmaceutical Review
SEPTEMBER 26, 2023
The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Sandoz has the rights to commercialise and distribute it in all markets under the deal.
Express Pharma
MAY 22, 2024
Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharma in Brief
JUNE 21, 2020
On November 29, 2019, the PMPRB launched a 60-day consultation on its first set of Draft Guidelines to implement the amended Regulations. Medicines with an annual treatment cost >150% of GDP/capita or maximum expected market size >$50 M will be classified as Category I, except biosimilars and generics.
FDA Law Blog: Biosimilars
SEPTEMBER 23, 2024
1999P-2778) “request[ing] FDA disclose to the public through its Web site (1) the name of the innovator drug and approved dosage strengths, (2) the date the first Paragraph IV-containing ANDA is submitted, and (3) the dosage strengths included in that ANDA.” On October 4, 2000, a second Citizen Petition (FDA Legacy Docket No.
PharmaShots
APRIL 26, 2023
The report is concluded with an engaging SWOT analysis and edifying KOL reviews Active Ingredient: Dupilumab Dosage Forms & Strengths: Single-Dose Pre-Filled Syringe with Needle Shield Injection: 300 mg/2 mL, 200 mg/1.14 mL, 100 mg/0.67 mL Single-Dose Pre-filled pen Injection: 300 mg/2 mL, 200 mg/1.14
PharmaShots
JUNE 28, 2023
The increase in ENBREL sales for 2019 vs 2018 was primarily driven by favorable changes to estimated sales deductions and an increase in net selling price, partially offset by lower unit demand. Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. Enbrel Prescribing Information 3.
Pharma in Brief
JANUARY 25, 2023
Changes to how the PMPRB reviews prices In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). A consultation on the proposed changes took place in 2019. The Federal Court ( FC ) and Federal Court of Appeal ( FCA) continued to develop substantive patent law.
Expert insights. Personalized for you.
59 
Let's personalize your content