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Also known as: Trastuzumab dm1 , trastuzumab mcc dm1 , trastuzumab mcc dm1 antibody drug conjugate , trastuzumab mcc dm1 immunoconjugate
Trastuzumab emtansine is a recombinant IgG1 kappa, humanized monoclonal antibody, andbiosimilar to Herceptin.

API SUPPLIERS

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LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
LGM Pharma CB

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Shanghai Minbiotech

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shanghai Minbiotech CB
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Listed Suppliers

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LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Trastuzumab Emtansine

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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Trastuzumab Emtansine

About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
Shanghai Minbiotech CB
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Drugs in Development

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Details:

Kadcyla (trastuzumab emtansine) is a HER2 modulator, antibody-drug conjugate. It is being evaluated in phase 3 clinical trials for the treatment of HER2-positive early-stage breast cancer.


Lead Product(s): Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Kadcyla

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 08, 2023

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F. Hoffmann-La Roche

Switzerland
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F. Hoffmann-La Roche

Switzerland
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Details : Kadcyla (trastuzumab emtansine) is a HER2 modulator, antibody-drug conjugate. It is being evaluated in phase 3 clinical trials for the treatment of HER2-positive early-stage breast cancer.

Brand Name : Kadcyla

Molecule Type : Large molecule

Upfront Cash : Not Applicable

December 08, 2023

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Details:

TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein and in combination with ado-trastuzumab emtansine is being developed in patients with HER2-positive metastatic or unresectable breast cancer.


Lead Product(s): Tucatinib,Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Tukysa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2023

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Seagen

U.S.A
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Seagen

U.S.A
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Details : TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein and in combination with ado-trastuzumab emtansine is being developed in patients with HER2-positive metastatic or unresectable breast cancer.

Brand Name : Tukysa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 06, 2023

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Details:

Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need.


Lead Product(s): Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Ujvira

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 24, 2021

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Details : Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need.

Brand Name : Ujvira

Molecule Type : Large molecule

Upfront Cash : Not Applicable

May 24, 2021

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Details:

Approval is based on the study which evaluated the efficacy and safety of Kadcyla adjuvant therapy in patients with HER2-positive early breast cancer who did not have pathologic complete response following neoadjuvant therapy including Herceptin.


Lead Product(s): Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Kadcyla

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 21, 2020

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Details : Approval is based on the study which evaluated the efficacy and safety of Kadcyla adjuvant therapy in patients with HER2-positive early breast cancer who did not have pathologic complete response following neoadjuvant therapy including Herceptin.

Brand Name : Kadcyla

Molecule Type : Large molecule

Upfront Cash : Not Applicable

August 21, 2020

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FDF Dossiers

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F. Hoffmann-La Roche

Switzerland
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F. Hoffmann-La Roche

Switzerland
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trastuzumab emtansin

Brand Name : Kadcyla

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 100MG/VIAL

Packaging : 15ML/20ML

Approval Date :

Application Number : 2412365

Regulatory Info : Prescription

Registration Country : Canada

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 160MG/VIAL

Packaging :

Approval Date :

Application Number : 2473224

Regulatory Info : Prescription

Registration Country : Canada

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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Trastuzumab Emtansine

Brand Name : Kadcyla 100

Dosage Form : INF

Dosage Strength : 100mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla 160

Dosage Form : INF

Dosage Strength : 160mg

Packaging : 8X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

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Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

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Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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trastuzumab emtansine

Brand Name : Kadcyla

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Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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trastuzumab emtansine

Brand Name : Kadcyla

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Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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F. Hoffmann-La Roche

Switzerland
Medlab Asia & Asia Health
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

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Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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Europe

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trastuzumab emtansin

Brand Name : Kadcyla

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 100 MG

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Approval Date :

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Registration Country : Sweden

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trastuzumab emtansin

Brand Name : Kadcyla

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 160 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Canada

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TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 100MG/VIAL

Packaging : 15ML/20ML

Approval Date :

Application Number : 2412365

Regulatory Info : Prescription

Registration Country : Canada

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Medlab Asia & Asia Health
Not Confirmed
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TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 160MG/VIAL

Packaging :

Approval Date :

Application Number : 2473224

Regulatory Info : Prescription

Registration Country : Canada

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Australia

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trastuzumab emtansine

Brand Name : Kadcyla

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Registration Country : Australia

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Brand Name : Kadcyla

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Registration Country : Australia

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Brand Name : Kadcyla

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Registration Country : Australia

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Brand Name : Kadcyla

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Brand Name : Kadcyla

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Brand Name : Kadcyla

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Brand Name : Kadcyla

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Approval Date :

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Regulatory Info :

Registration Country : Australia

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South Africa

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Trastuzumab Emtansine

Brand Name : Kadcyla 100

Dosage Form : INF

Dosage Strength : 100mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Medlab Asia & Asia Health
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Trastuzumab Emtansine

Brand Name : Kadcyla 160

Dosage Form : INF

Dosage Strength : 160mg

Packaging : 8X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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DATA COMPILATION #PharmaFlow

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Top drugs and pharmaceutical companies of 2019 by revenues
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

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https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

#PharmaFlow by PHARMACOMPASS
29 Apr 2020

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