Osimert 80 mg is identified on this website as a product containing osimertinib, an oral targeted anticancer medicine belonging to the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor class.
Osimertinib is used in selected adults with non-small cell lung cancer (NSCLC) whose tumors contain specific EGFR alterations. The appropriate indication depends on the tumor’s molecular characteristics, disease stage, previous treatment, combination therapy and the regulatory requirements applicable in the country where treatment is provided.
The specific manufacturer, marketing authorization holder and regulatory status of the Osimert-branded product should be confirmed from the product packaging and applicable regulatory documentation.
Everest Pharmaceuticals Ltd. is a pharmaceutical manufacturer based in Bangladesh. The company is involved in the development, production, and marketing of pharmaceutical products, including medicines used in specialized therapeutic areas.
Everest Pharmaceuticals focuses on manufacturing quality medicines for the healthcare market and offers a range of products, including treatments used in oncology and other medical fields. Its product portfolio includes various generic medicines formulated for patients and healthcare providers.
Company Name: Everest Pharmaceuticals Ltd.
Industry: Pharmaceutical Manufacturing
Country: Bangladesh
Business Activities: Manufacturing, marketing, and distribution of pharmaceutical products
Product Areas: Includes specialized and general pharmaceutical medicines
Quality Focus: Product manufacturing and quality-control processes are intended to support medicine quality, safety, and regulatory compliance.
For product-specific information, it is important to check the official packaging, product insert, batch details, and manufacturer information, as formulations and regulatory status may vary by product and market.
Head Office: Everest Pharmaceuticals Ltd. is located at Rahman’s Regnum Centre (10th & 11th floor), 191/1 Tejgaon Commercial Area, Dhaka-1208, Bangladesh.
Manufacturing Plant: Everest Pharmaceuticals Limited B-33, 45 & 46, BSCIC, Kanchpur, Narayanganj–1430, Bangladesh
| Information | Details |
|---|---|
| Product name | Osimert |
| Active ingredient | Osimertinib |
| Strength | 80 mg |
| Dosage form | Tablet, subject to product documentation |
| Route | Oral |
| Drug class | EGFR tyrosine kinase inhibitor |
| Therapeutic area | Oncology |
| Main disease area | Non-small cell lung cancer |
| Product manufacturer | Everest Pharmaceuticals Ltd., Bangladesh, as identified in the supplied product information |
| Reference/originator product | Tagrisso (osimertinib) |
| Reference/originator company | AstraZeneca |
| Original developer | AstraZeneca |
| Prescription status | Prescription anticancer medicine |
| Key biomarker | EGFR alterations, depending on indication |
Osimertinib is an oral, third-generation, irreversible EGFR tyrosine kinase inhibitor.
EGFR is a receptor involved in signaling pathways that can regulate cell growth and survival. Certain activating EGFR alterations can drive the growth and progression of NSCLC.
Osimertinib is designed to inhibit mutant forms of EGFR, including clinically important alterations such as EGFR exon 19 deletions, exon 21 L858R mutations and the EGFR T790M resistance mutation, depending on the treatment setting.
Because osimertinib targets specific molecular abnormalities, molecular testing is an important part of determining whether a patient may be eligible for treatment.
The FDA’s original U.S. approval of Tagrisso occurred in 2015, initially for metastatic EGFR T790M mutation-positive NSCLC after progression on or following EGFR TKI therapy.
Osimertinib is used in several EGFR-mutated NSCLC treatment settings. Approved indications differ between countries and can change as regulatory authorities review new clinical evidence.
Depending on the applicable authorization, osimertinib may be used for:
For example, the FDA approved osimertinib with platinum-based chemotherapy in February 2024 for certain patients with locally advanced or metastatic NSCLC containing EGFR exon 19 deletions or exon 21 L858R mutations.
The FDA subsequently approved osimertinib in September 2024 for certain adults with unresectable stage III EGFR exon 19 deletion- or exon 21 L858R-positive NSCLC after platinum-based chemoradiation.
A patient’s eligibility cannot be determined from the product name alone. Tumor testing, disease stage, previous treatment and the applicable local prescribing information must all be considered.
Osimert contains the active ingredient osimertinib.
Tagrisso is the established reference/originator brand associated with osimertinib and AstraZeneca. FDA records identify AstraZeneca Pharmaceuticals as the sponsor of osimertinib’s original U.S. approval, while AstraZeneca’s own materials identify Tagrisso as its osimertinib medicine.
Osimert should not automatically be described as identical to Tagrisso merely because both products contain osimertinib.
The following may differ between products:
Therefore, product-specific documentation should be used when describing Osimert.
AstraZeneca developed osimertinib and brought it to market under the brand name Tagrisso.
FDA records show AstraZeneca Pharmaceuticals as the sponsor associated with osimertinib’s original U.S. approval. Tagrisso received its initial U.S. approval in November 2015.
AstraZeneca’s European announcement also identified Tagrisso as AZD9291 (osimertinib) and described the 80 mg once-daily tablet authorization in the European Union in 2016.
For website purposes, it is more accurate to distinguish originator/developer, reference-product manufacturer, and manufacturer of a particular generic or alternative branded product.
The documented originator/reference product is Tagrisso, developed and marketed by AstraZeneca. AstraZeneca was therefore the company responsible for the originator medicine’s development and initial commercial introduction.
However, the fact that AstraZeneca developed and marketed Tagrisso does not establish that AstraZeneca manufactures every osimertinib product sold worldwide.
For Osimert 80 mg specifically, the supplied product information identifies Everest Pharmaceuticals Ltd. in Bangladesh as the manufacturer. This product-specific manufacturing claim should be checked against the current packaging, official manufacturer documentation and applicable regulatory records before publication.
Osimertinib works by inhibiting EGFR tyrosine kinase signaling.
Certain EGFR mutations can cause abnormal signaling that encourages cancer cells to grow and survive. Osimertinib binds irreversibly to mutant EGFR and interferes with signaling associated with these cancer-driving alterations.
Important EGFR alterations relevant to osimertinib treatment include:
The exact mutation requirement depends on the treatment indication.
The EGFR T790M mutation can contribute to resistance to earlier-generation EGFR tyrosine kinase inhibitors.
Osimertinib was initially developed as a targeted treatment capable of inhibiting mutant EGFR, including T790M, while maintaining activity against important activating EGFR mutations.
Osimertinib has clinically relevant central nervous system activity. This is particularly important in EGFR-mutated NSCLC because the disease can involve the brain and other areas of the central nervous system.
Treatment decisions involving brain metastases should be made by the treating oncology team according to the applicable indication and clinical circumstances.
The appropriate osimertinib dose depends on the indication and applicable regulatory labeling.
For several approved adult indications, the standard osimertinib dose is 80 mg orally once daily.
However, dosage should not be individualized solely from information on this website.
Dose modification or treatment interruption may be required for certain adverse reactions or clinical circumstances.
The original U.S. Tagrisso labeling identified 80 mg once daily as the recommended dosage for its initial approved indication.
If a dose of osimertinib is missed, patients should follow the instructions in the applicable current prescribing information.
Do not take an extra dose unless specifically instructed by a healthcare professional.
Because instructions can depend on the product labeling and circumstances surrounding the missed dose, the official patient information supplied with the medicine should be consulted.
Osimertinib has been marketed in different strengths depending on jurisdiction and product.
The reference product Tagrisso has been marketed as 40 mg and 80 mg tablets. AstraZeneca’s European authorization announcement identified both 40 mg and 80 mg once-daily tablets.
For this website, Osimert 80 mg is identified as the 80 mg product.
| Strength | Active ingredient |
| Osimert 80 mg | 80 mg osimertinib |
The exact dosage form, packaging and commercial presentation of Osimert should be confirmed against the product’s official documentation.
Osimertinib can cause adverse reactions ranging from relatively common effects to potentially serious complications.
Commonly reported adverse reactions may include:
The frequency and severity of adverse reactions can vary according to treatment setting, combination therapy, treatment duration and individual patient characteristics.
The original FDA Tagrisso label identified diarrhea, rash, dry skin and nail toxicity among the most common adverse reactions.
Osimertinib can cause serious adverse reactions and requires appropriate medical supervision.
Important safety considerations include:
Osimertinib can cause inflammation or injury of lung tissue. New or worsening respiratory symptoms should be promptly evaluated.
Osimertinib can prolong the QT interval, potentially increasing the risk of abnormal heart rhythms in susceptible patients.
Reduced heart function has been reported. Appropriate patients may require cardiac monitoring during treatment.
Eye-related adverse reactions can occur. Significant eye pain, redness, vision changes or other concerning symptoms should be evaluated by a healthcare professional.
Rash, dry skin and nail changes are recognized adverse effects.
Diarrhea is common and can become clinically significant if severe or prolonged.
Osimertinib may cause fetal harm. Pregnancy and reproductive considerations should be discussed with an appropriate healthcare professional before treatment.
The applicable prescribing information should be consulted for the complete list of warnings, precautions and adverse reactions.
Osimertinib may cause fetal harm.
Patients who are pregnant, planning pregnancy or who could become pregnant should discuss the risks and appropriate contraception requirements with their healthcare professional.
Pregnancy-related recommendations can differ depending on sex, reproductive potential, treatment combination and applicable regulatory labeling.
Do not make reproductive-health decisions based solely on website information.
Osimertinib treatment may require interruption or avoidance of breastfeeding depending on the applicable prescribing information.
The original U.S. Tagrisso labeling instructed patients not to breastfeed during treatment.
Patients should consult the current local prescribing information and their healthcare professional for the most appropriate recommendation.
Osimertinib can interact with other medicines.
Particular attention may be required with medicines that influence CYP3A activity or medicines that can themselves affect cardiac rhythm or the QT interval.
The original FDA labeling specifically addressed strong CYP3A inhibitors and strong CYP3A inducers.
Patients should provide their healthcare professional with a complete list of:
Do not start or stop another medicine without professional advice when receiving osimertinib.
Monitoring depends on the patient’s diagnosis, treatment regimen and clinical history.
Healthcare professionals may assess:
The precise monitoring plan should be determined by the treating oncology team.
Osimertinib has been evaluated extensively in EGFR-mutated NSCLC.
Clinical development has included studies evaluating:
The FDA’s 2024 approval of osimertinib plus platinum-based chemotherapy was based on the FLAURA2 study, which enrolled patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive locally advanced or metastatic NSCLC.
The 2024 approval for unresectable stage III disease followed results from the LAURA study.
Clinical-trial results should not be interpreted as a prediction of an individual patient’s response.
Osimertinib is a biomarker-directed treatment.
Before using osimertinib for an indication requiring an EGFR alteration, appropriate molecular testing is generally necessary to establish whether the tumor contains the relevant biomarker.
Depending on the indication, testing may evaluate:
FDA companion-diagnostic information identifies EGFR biomarkers relevant to Tagrisso treatment.
A negative blood-based test does not necessarily exclude a tumor alteration in every clinical circumstance, so the treating team may determine whether tissue-based testing is appropriate.
Osimertinib is generally classified as a targeted anticancer therapy, specifically an EGFR tyrosine kinase inhibitor.
It is different from conventional cytotoxic chemotherapy because it is designed to target specific molecular signaling associated with EGFR-driven cancer.
However, osimertinib can also be used in combination with platinum-based chemotherapy for certain patients with EGFR-mutated NSCLC under applicable regulatory indications.
To verify the authenticity of an Everest Pharmaceuticals product, follow the verification process below:
Scan the QR Code: Scan the QR code printed on the product box.
The QR code will direct you to the official product verification page.
The QR code will direct you to the Everest Pharmaceuticals Ltd. E-Verification page, where you can complete the product verification process.
Open the Box: After accessing the verification page, open the product box and locate the verification code printed on the bottle.
Submit the Verification Code: Enter the verification code from the bottle on the verification page and submit it to check the product’s authenticity.
Verification Success: If the verification is successful, the product is confirmed as legitimate.
Verification Error: If the system displays a verification error, the product may be counterfeit or unauthorized. Do not use the product until its authenticity has been confirmed through an appropriate official channel.
Counterfeit Products: If a product is confirmed to be fake, do not use or distribute it. Report the suspected counterfeit product and supplier to the appropriate regulatory authorities, such as the Directorate General of Drug Administration (DGDA) in World, and take appropriate legal action against the supplier through the relevant authorities.
Important: Always purchase medicines from licensed pharmacies or authorized suppliers and verify suspicious products before use.
For this website, Osimert 80 mg is identified as being manufactured by Everest Pharmaceuticals Ltd. in Bangladesh, based on the supplied product information.
This product-specific statement should be verified against current packaging and official manufacturer or regulatory documentation before publication.
It is important to distinguish this manufacturer information from the originator history of osimertinib.
AstraZeneca developed osimertinib and introduced it as Tagrisso.
Tagrisso (osimertinib) is the established originator/reference brand.
Everest Pharmaceuticals Ltd., Bangladesh, according to the supplied product information.
The company that developed a medicine is not necessarily the company that manufactures every product containing the same active ingredient.
A pharmaceutical product may have separate entities for:
These roles should not be presented as interchangeable.
Osimert 80 mg is a prescription anticancer medicine.
The information on this website is intended for general educational purposes and does not replace professional medical advice, diagnosis, prescribing information or individualized treatment.
Patients should not start, stop, increase or decrease osimertinib based solely on information published online.
Approved indications, dosage recommendations, warnings, formulations and regulatory requirements may differ between countries and may change over time.
Always consult the latest official product information and an appropriately qualified healthcare professional.
Osimert 80 mg is identified on this website as an 80 mg product containing osimertinib, an EGFR tyrosine kinase inhibitor used in selected patients with EGFR-mutated NSCLC.
Osimertinib is used in selected EGFR-mutated NSCLC treatment settings, including certain early-stage, locally advanced and metastatic disease settings depending on the applicable regulatory authorization.
Osimert and Tagrisso contain the same active ingredient, osimertinib, but they are different branded products. Tagrisso is the originator/reference product associated with AstraZeneca.
AstraZeneca developed osimertinib and introduced it as Tagrisso. FDA records identify AstraZeneca Pharmaceuticals as the sponsor of the original U.S. approval.
The supplied product information identifies Everest Pharmaceuticals Ltd. in Bangladesh as the manufacturer of Osimert 80 mg. This product-specific information should be confirmed against current official documentation.
The major reference/originator product is Tagrisso, developed and marketed by AstraZeneca.
Osimertinib is a targeted anticancer medicine and EGFR tyrosine kinase inhibitor rather than conventional cytotoxic chemotherapy.
Osimertinib irreversibly inhibits mutant EGFR signaling, including clinically important EGFR alterations relevant to NSCLC treatment.
EGFR, or epidermal growth factor receptor, is a cell-surface receptor involved in signaling pathways that regulate cell growth and survival. Certain EGFR alterations can drive NSCLC.
Depending on the indication, clinically relevant alterations include EGFR exon 19 deletions, exon 21 L858R mutations and T790M.
For biomarker-defined indications, molecular testing is important to establish whether the tumor contains the relevant EGFR alteration.
For several approved adult indications, osimertinib is administered orally once daily. The exact regimen depends on the indication and applicable prescribing information.
Osimertinib has been marketed in 40 mg and 80 mg tablet strengths in the reference product. Osimert 80 mg is identified here as an 80 mg product.
Common adverse reactions can include diarrhea, rash, dry skin, nail changes and fatigue.
Yes. Cardiac effects, including QT interval prolongation and cardiomyopathy, are important safety considerations.
Yes. Interstitial lung disease and pneumonitis are important potential adverse reactions requiring prompt evaluation of concerning respiratory symptoms.
Osimertinib may cause fetal harm. Pregnancy and reproductive considerations should be discussed with a healthcare professional before treatment.
The original U.S. Tagrisso labeling advised against breastfeeding during treatment. Patients should follow the current applicable prescribing information.
Potential drug interactions exist. Patients should provide their healthcare professional with a complete medication and supplement list.
Dose interruption or modification may be required for certain adverse reactions. Dose changes should only be made according to the treating healthcare professional’s instructions.
No. Osimertinib is a biomarker-directed treatment and is intended for specific NSCLC populations defined by EGFR alterations and treatment setting.
Osimertinib has clinically relevant central nervous system activity, but management of brain metastases must be individualized by the oncology team.
Follow the current patient information supplied with the product or contact the treating healthcare professional. Do not take an additional dose unless instructed.
The term “generic” should only be used when supported by the applicable regulatory classification. Osimert contains the same active ingredient as Tagrisso, but its exact regulatory status and relationship to the reference product should be verified in the relevant jurisdiction.
Information concerning the specific Osimert 80 mg product, including its manufacturer, packaging, authorization status and commercial supply chain, should be confirmed against current product documentation.
Osimert 80 mg is presented on this website as an osimertinib-containing product. The originator/reference medicine is Tagrisso, associated with AstraZeneca, which developed osimertinib.
The supplied product information identifies Everest Pharmaceuticals Ltd., Bangladesh as the manufacturer of Osimert 80 mg. This manufacturer statement should be supported by current packaging, official manufacturer documentation or a relevant regulatory record before publication.
The distinction between originator, reference product, manufacturer, marketing authorization holder, distributor and supplier should be maintained throughout the website to avoid implying that an alternative branded product is manufactured by or identical to AstraZeneca’s Tagrisso.
All medical and regulatory information should be reviewed against the latest applicable local prescribing information before publication.
Osimertinib is a targeted cancer medicine known as an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. It is designed to block signaling from specific mutant forms of EGFR involved in certain types of non-small cell lung cancer.
Osimertinib is used in specific treatment settings involving EGFR alterations such as exon 19 deletions and exon 21 L858R. It also has activity against the EGFR T790M resistance mutation in the appropriate clinical setting. Eligibility depends on the applicable regulatory indication and molecular test results.
EGFR testing helps determine whether a tumor contains an alteration that may make it suitable for EGFR-targeted treatment. The appropriate test and mutation requirements depend on the specific indication and applicable regulatory guidance.
Treatment duration depends on the indication, treatment response, disease status and tolerability. In some approved settings, treatment continues until disease progression or unacceptable toxicity, while adjuvant treatment may have a defined treatment duration.
Osimertinib has demonstrated activity in the central nervous system and can be used in appropriate patients with EGFR-mutated NSCLC according to the applicable treatment indication. Management of brain metastases should be determined by the oncology team.
Monitoring may include clinical assessment, blood tests, ECG evaluation and heart-function assessment when appropriate. The exact monitoring plan depends on the patient's medical history, treatment setting, risk factors and prescribing information.
Yes. Certain medicines can affect osimertinib exposure or increase concerns about adverse effects. Patients should tell their healthcare professional about all prescription medicines, over-the-counter products, supplements and herbal products they use.
Yes. Osimertinib can prolong the QTc interval, which may affect heart rhythm in susceptible patients. Healthcare professionals may consider ECG and electrolyte monitoring when clinically appropriate, particularly in patients with relevant risk factors.
Tell your healthcare professional about your cancer diagnosis and EGFR test results, other medical conditions, previous treatments, current medicines, allergies, pregnancy or plans for pregnancy, breastfeeding, and any history of heart, lung or eye problems.
Some cancers can develop acquired resistance to targeted treatment, including osimertinib. Resistance may involve additional EGFR changes or alternative biological pathways. If disease progression is suspected, the oncology team may consider appropriate clinical assessment and molecular testing.
