Insulin glargine

FTC Files Amicus Brief Outlining Anticompetitive Harm Caused by Improper Orange Book Listings

Retrieved on: 
Wednesday, January 3, 2024

Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process.

Key Points: 
  • Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process.
  • In September, the FTC issued a policy statement which warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book.
  • The Commission’s statement warned that improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high.
  • In November, the FTC sent letters to 10 drug manufacturers notifying them of more than 100 improperly listed Orange Book patents.

Biocon Biologics Successfully Completes Integration of Viatris’ Biosimilar Business in 31 Countries in Europe

Retrieved on: 
Thursday, November 30, 2023

BENGALURU, India, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris’ biosimilars business in 31 European countries has been successfully completed.

Key Points: 
  • BENGALURU, India, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris’ biosimilars business in 31 European countries has been successfully completed.
  • In Europe, Biocon Biologics portfolio includes 7 biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab, Adalimumab, and Etanercept.
  • At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, ophthalmology, and bone health.
  • Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: “The integration of the Viatris’ biosimilar business in Europe ahead of schedule is another important milestone for Biocon Biologics in our journey as a global biosimilars leader.

RxGo.com Offers Free Money Saving Coupons on Commonly Prescribed Diabetes Medications in Time for National Diabetes Month

Retrieved on: 
Wednesday, November 22, 2023

DENVER, Nov. 22, 2023 /PRNewswire-PRWeb/ -- In November, communities nationwide unite for National Diabetes Month to raise awareness about diabetes. This year emphasizes proactive measures to prevent health complications associated with diabetes. Diabetes, characterized by elevated blood glucose levels, impacts around 37 million Americans, posing risks to the eyes, kidneys, nerves, and heart, and increasing the likelihood of certain cancers.

Key Points: 
  • November marks National Diabetes Month, where communities nationwide emphasize preventing diabetes-related health issues, including taking medications on time.
  • Freestyle Libre 3 is actually not a medication but a small discrete glucose monitor for people with diabetes.
  • RxGo.com encourages people with a prescription for this drug to access a Metformin coupon today and immediately begin saving money.
  • It is prescribed for adults with type 1 or type 2 diabetes and for children aged at least 6 years with type 1 diabetes.

Press Release: Sanofi delivers first medicines from Global Health Unit’s Impact brand portfolio

Retrieved on: 
Thursday, October 19, 2023

Sanofi has delivered the first medicines from its Global Health Unit’s not-for-profit Impact brand portfolio to the Republic of Djibouti.

Key Points: 
  • Sanofi has delivered the first medicines from its Global Health Unit’s not-for-profit Impact brand portfolio to the Republic of Djibouti.
  • With this first shipment to Djibouti, Sanofi delivers on its commitment to improve and accelerate affordable and sustainable access to quality medicines, vaccines and healthcare for underserved populations.
  • To that point, the GHU created Impact, a unique not-for-profit brand with 30 standard-of-care medicines produced by Sanofi, some of which are considered "essential" by the World Health Organization (WHO).
  • “I'm delighted to see the very first Impact brand medicine, Enoxaparin Sodium Impact, arrive on Djibouti soil.

GoodRx Announces New Way for Consumers to Access Sanofi’s Lantus for $35 at Over 70,000 Pharmacies Nationwide

Retrieved on: 
Thursday, October 19, 2023

Sanofi is taking action and providing Americans who need insulin with the ability to access Lantus in an easy and affordable way, regardless of insurance status.

Key Points: 
  • Sanofi is taking action and providing Americans who need insulin with the ability to access Lantus in an easy and affordable way, regardless of insurance status.
  • We’re proud to collaborate with them on this initiative,” said Dorothy Gemmell, Chief Commercial Officer at GoodRx.
  • Patients can visit GoodRx.com/lantus to access the $35 price coupon, which can be redeemed at any pharmacy that accepts GoodRx, including CVS, Walgreens, and Walmart.
  • This complements other savings programs already offered by Sanofi, including offering Lantus for $35 per month to people without insurance.

Meitheal Pharmaceuticals Joins Biosimilars Forum

Retrieved on: 
Tuesday, October 17, 2023

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company based in Chicago, today announced it has joined the Biosimilars Forum, a growing coalition of companies that work together to make safe, effective and lower-cost biosimilars accessible to the patients that need them.

Key Points: 
  • Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company based in Chicago, today announced it has joined the Biosimilars Forum, a growing coalition of companies that work together to make safe, effective and lower-cost biosimilars accessible to the patients that need them.
  • “As a fully integrated biopharmaceutical company, Meitheal is thrilled to join the Biosimilars Forum,” said Tom Shea, CEO of Meitheal.
  • The Biosimilars Forum, a coalition of companies with the most significant biosimilars development portfolios in the U.S. and globally, is actively working to advance biosimilars in the U.S., with the ultimate goals of broadening access, enhancing availability and improving healthcare outcomes.
  • “The Biosimilars Forum is committed to fostering a competitive marketplace that enables safe, effective and lower-cost biosimilars to thrive.”
    Meitheal’s corporate purpose is to simplify access to life changing medicine, for good.

Meitheal Announces Exclusive Commercial Licensing Agreement for Insulin Biosimilars in the U.S.

Retrieved on: 
Thursday, September 21, 2023

THDB and NKF entered into strategic cooperation and will be jointly responsible for the development and supply of the three products.

Key Points: 
  • THDB and NKF entered into strategic cooperation and will be jointly responsible for the development and supply of the three products.
  • Upon approval, THDB, NKF and Meitheal will receive royalties on all product sales in the United States.
  • “This collaboration reinforces the strength of NKF’s partnership with Meitheal and demonstrates our commitment to innovation and continued investment in our portfolio companies,” said Eric Tang, President of NKF.
  • “We look forward to bringing these three products one step closer to patients through this strategic partnership.”

Lannett Successfully Emerges From Chapter 11 in Significantly Stronger Financial Position as the Company Remains on Track Toward Commercialization of Highly Promising Pipeline

Retrieved on: 
Friday, June 16, 2023

Compilation of the Company’s Biologics License Application (the “BLA”) for insulin glargine will be essentially complete in July and ready for filing.

Key Points: 
  • Compilation of the Company’s Biologics License Application (the “BLA”) for insulin glargine will be essentially complete in July and ready for filing.
  • Through its financial restructuring, the Company reduced its debt by approximately $600 million, equitizing over $500 million of the Company’s prepetition senior secured debt.
  • Chief Executive Officer Tim Crew, who continues as a Company board member, will be joined by Jeffrey D. Goldberg and Jason Shandell.
  • Both seasoned executives bring a wealth of experience and industry expertise to the Company to further guide Lannett’s strategic direction and future success.

Spending on antidiabetic drugs in Canada outpaced overall drug market

Retrieved on: 
Tuesday, May 30, 2023

The Patented Medicine Prices Review Board (PMPRB), through the National Prescription Drug Utilization Information System (NPDUIS) research initiative, today published the latest edition of the Market Intelligence Report: Antidiabetic Drugs, 2012-2021, which examines the market for drugs used in the treatment of diabetes.

Key Points: 
  • The Patented Medicine Prices Review Board (PMPRB), through the National Prescription Drug Utilization Information System (NPDUIS) research initiative, today published the latest edition of the Market Intelligence Report: Antidiabetic Drugs, 2012-2021, which examines the market for drugs used in the treatment of diabetes.
  • This fourth report in the Market Intelligence series analyzes the market for drugs used in the treatment of diabetes.
  • Antidiabetic drug growth outpaced the overall drug market, effectively doubling the market share for these drugs from 4.2% to 7.9% (2012 to 2021).
  • These drugs were responsible for almost all of Canada's increase in cost per capita of antidiabetic drugs since 2012.

Samsung Bioepis Releases its First US Biosimilar Market Report, Providing Insights on Pricing Trends and Usage Across Molecules

Retrieved on: 
Monday, April 17, 2023

The first quarterly report details the most recent price trends of all molecules for which biosimilars have launched, along with insights into interchangeability of biosimilars.

Key Points: 
  • The first quarterly report details the most recent price trends of all molecules for which biosimilars have launched, along with insights into interchangeability of biosimilars.
  • “The first edition of Biosimilar Market Report from Samsung Bioepis reveals that market competition stimulated by the introduction of biosimilars in the US has contributed to significant price reductions in the biologics market.
  • However, the level of biosimilar usage varies by molecule, with some still taking less than 50% of the market share.
  • Insulin glargine and adalimumab categories reflect recent pricing practices such as unbranded biologics and high/low wholesale acquisition cost (WAC) options.