Tagged as: Etanercept

BREAKING NEWS - HHS Announces the First 10 Drugs Selected for IRA Drug Price Negotiation Program

HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…

Read More

Biocon Completes Integration of Viatris Biosimilars Business

As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc.  This week Biocon announced that it had “completed the integration of the acquired biosimilars business in over 70 countries in Emerging…

Read More

Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

Read More

Biocon Biologics Confirms Completion of Multi-Billion Dollar Acquisition of Viatris’ Global Biosimilars Business

As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…

Read More

Lupin Announces Approval of ENBREL Biosimilar in Canada

On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada.  Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic, and respiratory disease treatments.  RYMTI is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial…

Read More

Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue.  It reported the following YoY revenue for each…

Read More

Health Canada Approves Merck’s Etanercept Biosimilar for New Indications

On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications: Adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy; Pediatric patients ages 4 to 17…

Read More

Lupin, Mylan Launch Etanercept Biosimilar in Germany

Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled…

Read More

Divided Federal Circuit Affirms Result in Immunex v. Sandoz Etanercept Litigation

We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture.  As we reported…

Read More

AryoGen’s bevacizumab biosimilar BE1040V found noninferior to AVASTIN in phase III study

In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer.  AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…

Read More