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Articles by Beth Ashbridge
California's Governor Newsom Announces That State Sponsored Insulin Pen Will Be Available Jan 1, 2026
Goodwin Procter LLP are most popular: within Transport topic(s) On October 17, Governor Newsom announced that California will be launching the "first and only" state contracted affordable insulin. Through an agreement with nonprofit generic drug manufacturer Civica Rx and Biocon Biologics, the interchangeable biosimilar insulin glargine pen CALRX will be available for purchase from January 1, 2026.
California’s Governor Newsom Announces that State Sponsored Insulin Pen will be Available Jan 1, 2026
On October 17, Governor Newsom announced that California will be launching the “first and only” state contracted affordable insulin. Through an agreement with nonprofit generic drug manufacturer Civica Rx and Biocon Biologics, the interchangeable biosimilar insulin glargine pen CALRX will be available for purchase from January 1, 2026.
Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ‘099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on October 30, 2024.
FDA Updates Guidance On Development Of Therapeutic Protein Biosimilars: Comparative Analytical Assessment & Other Quality-Related Considerations
This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry".
FDA Updates Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment & other Quality-Related Considerations
This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry”.
Samsung Bioepis Secures Marketing Approval In Korea For Its Biosimilar To Amgen's Bone Cancer Drug Xgeva
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen's bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions like unresectable giant cell tumors. Earlier this year, Samsung also received approval in Korea for a biosimilar to PROLIA, Amgen's other denosumab product used to treat hormone-induced bone loss and postmenopausal osteoporosis.
Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions like unresectable giant cell tumors. Earlier this year, Samsung also received approval in Korea for a biosimilar to PROLIA, Amgen’s other denosumab product used to treat hormone-induced bone loss and postmenopausal osteoporosis.
CuraTeQ Biologics' Trastuzumab Biosimilar Receives Positive Opinion In Europe
This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP).
CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe
This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP).
Celltrion Wins Costco Formulary Listing For Its Recently Launched Ustekinumab
Last week, we reported Celltrion's U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen's STELARA® (ustekinumab). According to Celltrion, STEQEYMA® is being sold at a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA®. This week, Celltrion announced that STEQEYMA® will be sold at Costco pharmacies across the United States under a new listing agreement with Costco Health Solutions, the pharmacy benefit manager arm of Costco.
Celltrion Wins Costco Formulary Listing for its Recently Launched Ustekinumab
Last week, we reported Celltrion’s U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen’s STELARA® (ustekinumab). According to Celltrion, STEQEYMA® is being sold at a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA®. This week, Celltrion announced that STEQEYMA® will be sold at Costco pharmacies across the United States under a new listing agreement with Costco Health Solutions, the pharmacy benefit manager arm of Costco.
Amgen Fires Back With Counterclaims In Aflibercept BPCIA Litigation
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen's aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 ("the '099 patent"). The '099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on October 30, 2024.
The 43rd Annual J.P. Morgan Healthcare Conference Starts Today - A Who's Who In Biologics At This Year's Conference
J.P Morgan states that the JP Morgan Healthcare Conference ("JPM") "is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community". On January 15, 2025, Goodwin and KPMG will host their 6th Annual Symposium. Life sciences companies have many opportunities to thrive in the face of changing tides.
The 43rd Annual J.P. Morgan Healthcare Conference Starts Today - A Who’s Who in Biologics at this Year’s Conference
The JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community”. On January 15, 2025, Goodwin and KPMG will host their 6th Annual Symposium. Life sciences companies have many opportunities to thrive in the face of changing tides.
Recent Biologics Deals
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (“ADC”) therapeutics, announced an exclusive option agreement with GSK for DualityBio’s ADC candidate, DB-1324, targeting gastrointestinal cancer.
Alvotech Requests that FDA Refuse to License CHO-Cell Derived Ustekinumab Biosimilars as Interchangeable Until the Effects of Sialylation Are Evaluated
Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary (“CHO”) cell line—and in particular Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe).
FTC Comment On FDA Draft Guidance On Interchangeability
We recently posted on a new FDA draft guidance entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers," aimed at providing "answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . .
FTC Comment on FDA Draft Guidance on Interchangeability
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . .
Acuitas File Complaint Against Alnylam For Declaratory Judgment Of Co-Inventorship Of Lipid Particle Patents
Acuitas Therapeutics Inc. ("Acuitas") filed a complaint (1-24-cv-00816) on July 12 against Alnylam Pharmaceutical Inc. ("Alnylam") in the U.S. District Court for the District of Delaware, alleging incorrect inventorship of seven U.S. Patents related to COVID-19 mRNA-LNP vaccines, namely U.S. Patent Nos.
Acuitas File Complaint Against Alnylam for Declaratory Judgment of Co-Inventorship of Lipid Particle Patents
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint (1-24-cv-00816) on July 12 against Alnylam Pharmaceutical Inc. (“Alnylam”) in the U.S. District Court for the District of Delaware, alleging incorrect inventorship of seven U.S. Patents related to COVID-19 mRNA-LNP vaccines, namely U.S. Patent Nos.
FDA Approves Boehringer Ingelheim's CYLTEZO® Biosimilar To Humira For Multiple Chronic Inflammatory Diseases
Earlier this month, FDA approved Boehringer Ingelheim's high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021. A lower concentration version of CYLTEZO (50 mg/mL) has been on the market since July 2023.
FDA Approves Boehringer Ingelheim’s CYLTEZO® Biosimilar to Humira for Multiple Chronic Inflammatory Diseases
Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021. A lower concentration version of CYLTEZO (50 mg/mL) has been on the market since July 2023.
FDA Approves BMS And J&J CAR-T Cell Therapies For The Earlier Treatment Of Multiple Myeloma
On April 4, 2024, Bristol Myers Squibb ("BMS") and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
FDA APPROVES BMS AND J&J CAR-T CELL THERAPIES FOR THE EARLIER TREATMENT OF MULTIPLE MYELOMA
On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
Women's History Month Spotlight: Emmanuelle Charpentier And Jennifer Doudna
In honor of Women's History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or "molecular scissors". By sharing the 2020 Nobel Prize in Chemistry, Charpentier and Doudna were the first women-only Nobel team in the history of the award and the sixth and seventh women, respectively, to win the Nobel Prize in Chemistry.
Women’s History Month Spotlight: Emmanuelle Charpentier and Jennifer Doudna
In honor of Women’s History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or “molecular scissors”. By sharing the 2020 Nobel Prize in Chemistry, Charpentier and Doudna were the first women-only Nobel team in the history of the award and the sixth and seventh women, respectively, to win the Nobel Prize in Chemistry.
Women’s History Month Spotlight: Emmanuelle Charpentier and Jennifer Doudna
In honor of Women’s History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or “molecular scissors”. By sharing the 2020 Nobel Prize in Chemistry, Charpentier and Doudna were the first women-only Nobel team in the history of the award and the sixth and seventh women, respectively, to win the Nobel Prize in Chemistry.
German Court Invalidates CureVac Patent In Ongoing BioNTech Lawsuit
On December 19, a German court invalidated CureVac's messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac against its rival BioNTech. CureVac, a biopharmaceutical company developing messenger RNA therapeutics for COVID-19 vaccines, announced that it will appeal the decision before the German Federal Court of Justice. This ruling represents the first decision on validity in the ongoing patent litigation between CureVac and BioNTech in Germany.
Year In Review: Top Deals In 2023
According to PWC, "2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels." Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Coya Announces Agreement with Dr. Reddy's Laboratories for Treatment of Neurodegenerative Diseases In March, Coya Therapeutics, Inc.
German Court Invalidates CureVac Patent in Ongoing BioNTech Lawsuit
On December 19, a German court invalidated CureVac’s messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac against its rival BioNTech. CureVac, a biopharmaceutical company developing messenger RNA therapeutics for COVID-19 vaccines, announced that it will appeal the decision before the German Federal Court of Justice. This ruling represents the first decision on validity in the ongoing patent litigation between CureVac and BioNTech in Germany.
German Court Invalidates CureVac Patent in Ongoing BioNTech Lawsuit
BioNTech, covid-19, CureVac On December 19, a German court invalidated CureVac’s messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac against its rival BioNTech. CureVac, a biopharmaceutical company developing messenger RNA therapeutics for COVID-19 vaccines, announced that it will appeal the decision before the German Federal Court of Justice.
Year in Review: Top Deals in 2023
According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Coya Announces Agreement with Dr. Reddy’s Laboratories for Treatment of Neurodegenerative Diseases In March, Coya Therapeutics, Inc.
Acuitas Files Suit Against CureVac Alleging Incorrect Inventorship On COVID MRNA-LNP Vaccine Patent Family
Acuitas Therapeutics Inc. ("Acuitas") filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Patent Nos. 11,241,493, 11,471,525, 11,576,966, and 11,596,686, (collectively, the "'493 Patent Family").
Acuitas Files Suit Against CureVac Alleging Incorrect Inventorship on COVID MRNA-LNP Vaccine Patent Family
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Patent Nos. 11,241,493, 11,471,525, 11,576,966, and 11,596,686, (collectively, the “’493 Patent Family”).
Acuitas Files Suit Against CureVac Alleging Incorrect Inventorship on COVID MRNA-LNP Vaccine Patent Family
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Patent Nos. 11,241,493, 11,471,525, 11,576,966, and 11,596,686, (collectively, the “’493 Patent Family”).
Amneal Expands Oncology Offering With Two Denosumab Biosimilars
On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries.
Amneal Expands Oncology Offering with Two Denosumab Biosimilars
On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries.
Amneal Expands Oncology Offering with Two Denosumab Biosimilars
On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries.
Celltrion Expands Access To YUFLYMA (Adalimumab-Aaty)
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) "who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM's." According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra's formulary.
Celltrion Expands Access to YUFLYMA (adalimumab-aaty)
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra’s formulary.
Celltrion Expands Access to YUFLYMA (adalimumab-aaty)
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra’s formulary.
Acuitas Seeks Declaratory Judgment Of Non-Infringement And Invalidity Against Arbutus And Genevant In New Jersey Court Challenging MRNA-Delivery Specific Patents - Patent - United States
Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to messenger RNA-delivery technology.
Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging mRNA-Delivery Specific Patents
Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to messenger RNA-delivery technology.
Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging mRNA-Delivery Specific Patents
Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to messenger RNA-delivery technology.
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.
Regeneron Received FDA Complete Response Letter For Its Higher Dose Aflibercept Injection BLA
Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter ("CRL") for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, "due to an ongoing review of inspection findings at a third-party filler," which has now been announced as Catalent's Bloomington site in Indiana.
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.
Regeneron Received FDA Complete Response Letter For Its Higher Dose Aflibercept Injection BLA
Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, “due to an ongoing review of inspection findings at a third-party filler,” which has now been announced as Catalent’s Bloomington site in Indiana.
Regeneron Received FDA Complete Response Letter For Its Higher Dose Aflibercept Injection BLA
Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, “due to an ongoing review of inspection findings at a third-party filler,” which has now been announced as Catalent’s Bloomington site in Indiana.
Alnylam Files New COVID-19 Vaccine Infringement Lawsuits Against Pfizer And Moderna
Last Friday, Alnylam Pharmaceuticals, Inc. ("Alnylam") filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in Delaware alleging their COVID-19 vaccine lipid nanoparticle technology infringes Alnylam's patent rights. The patents-in-suit are U.S. Patent Nos. 11,633,479 (the "'479 Patent"), 11,633,480 (the "'480 Patent"), and 11,590,229 (the "'229 Patent").
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