Aurobindo Pharma Limited, a global pharmaceutical company, has received marketing authorization from the European Medicines Agency (EMA) for its generic version of Zefylti, a medicine used to treat various blood and lymphatic disorders. Zefylti (Efalizumab) is a humanized monoclonal antibody that is used to treat moderate to severe atopic dermatitis (atopic eczema), also known as eczema, and plaque psoriasis.

According to the company, the marketing authorization is a significant milestone, marking the entry of Aurobindo Pharma into the dermatology segment. The company plans to leverage this product to further strengthen its presence in the EU market. The approval is likely to benefit patients in the region who require effective treatment for their skin conditions.

Zefylti is a biosimilar version of Raptiva, a marketed product of Genentech, part of Roche Group. The generic version of Zefylti is expected to offer cost savings to patients and the healthcare system while maintaining the same level of efficacy and safety as the originator product.

The EMA’s decision is based on Aurobindo Pharma’s comprehensive submission, which provided detailed data on the quality, safety, and efficacy of Zefylti. The company successfully demonstrated bioequivalence with the reference product, thereby meeting the required standards for biosimilarity.

The marketing authorization is valid for three years, during which Aurobindo Pharma will be responsible for supplying the product to the EU market. The company plans to enter into partnerships with pharmaceutical wholesalers and distributors to ensure widespread availability of Zefylti across the region.

This approval is a testament to Aurobindo Pharma’s commitment to delivering high-quality, affordable medicines to patients. The company has an extensive range of generic and specialty products in its pipeline, with a focus on critical care, dermatology, and ophthalmology. With this new approval, Aurobindo Pharma is poised to expand its presence in the EU market and contribute to improving patient outcomes.

Aurobindo, the largest generics company in the US by prescriptions dispensed, is preparing to launch its entire range of GLP-1 receptor agonists, including semaglutide, despite the uncertainty surrounding US tariffs on imports from China. The company has been diversifying its sources to ensure that it can maintain business continuity in the event of any disruption due to tariffs. This move comes as a relief to the pharmaceutical industry, which has been expressing concerns about the potential impact of US tariffs on imports from China on its operations.

Aurobindo’s preparations include having alternative suppliers and production lines in place, which will enable it to maintain its supply chain if one of its suppliers is affected by the tariffs. The company is also keeping a close eye on the developing situation and is working with its customers to ensure a smooth transition in the event of any disruption.

The company is set to launch its GLP-1 receptor agonist range, which includes semaglutide, in the coming months. The launch is expected to bring relief to patients who have been struggling to access these life-saving treatments. The GLP-1 receptor agonists are used to treat type 2 diabetes and are known for their effectiveness in helping patients manage their blood sugar levels.

Despite the uncertainty surrounding the tariffs, Aurobindo’s commitment to staying ahead of the curve means that it has alternative suppliers and production lines in place, ensuring that its operations will not be disrupted. The company’s focus on diversification and flexibility has helped it maintain its position as the largest generics company in the US by prescriptions dispensed.

In related news, Aurobindo has announced that it is setting up a new production line to manufacture its biosimilar products, including insulin and other hormone products. The company has also increased its production capacity to meet growing global demand for its biosimilars. This move is seen as a major boost to the generic drug industry, which has been facing challenges due to rising demand and regulatory hurdles.

Overall, Aurobindo’s commitment to diversification and flexibility in the face of uncertainty surrounding the US tariffs is a testament to its reputation for resilience and adaptability in the pharmaceutical industry. The company’s efforts to ensure business continuity and its commitment to launching its GLP-1 receptor agonist range, including semaglutide, are a positive sign for the industry and for patients who rely on these life-saving treatments.

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On February 13, President Trump imposed reciprocal tariffs on countries that impose duties on US exports. This move is a response to the tariffs imposed by other countries on American goods, particularly steel and aluminum. The move has raised concerns about potential disruptions to businesses and economic trade. Aurobindo, when asked about the impact of US tariffs, stated that they have alternative strategies in place to mitigate the effects of these tariffs.

The decision by President Trump to impose tariffs has sparked concern about potential disruptions to businesses, particularly those that rely heavily on international trade. The tariffs are seen as a protectionist measure aimed at protecting American industries, but they may also have negative consequences for businesses and consumers.

Aurobindo, a company that imports generic drugs, has been affected by the tariffs. Despite the uncertainty, Aurobindo has reportedly stated that they have alternative strategies in place to deal with the tariffs. This suggests that the company has been preparing for this eventuality and has contingency plans in place to minimize the impact on its business.

The imposition of tariffs has also raised concerns about the potential for retaliatory measures from other countries. This could lead to a cycle of tariffs and counter-tariffs, which could have significant economic consequences. The tariffs are also seen as a way for the US to flex its economic muscle, but they may also contribute to a broader trade war, which could have far-reaching consequences for the global economy.

In conclusion, the imposition of tariffs by President Trump has raised concerns about potential disruptions to businesses and the potential for a trade war. While Aurobindo has stated that they have alternative strategies in place, the impact on businesses and the global economy is still uncertain. The tariffs are seen as a protectionist measure, but they may also have negative consequences for the economy and global trade.

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Aurobindo Pharma, a leading Indian pharmaceutical company, has announced its standalone financial results for the month of December 2024. The company’s net sales for the month increased by 8.34% year-on-year (y-o-y) to stand at Rs 2,916.63 crore.

The company’s operational performance continues to be strong, driven by its diversified product portfolio and strategic expansion into new markets. The growth in net sales is attributed to a 7.51% increase in exports and a 9.22% increase in domestic sales.

The company’s revenue from exports was primarily driven by the strong demand for its key products, including generic formulations and active pharmaceutical ingredients (APIs). The domestic sales growth was driven by the company’s efforts to increase its presence in the Indian market, including its tie-ups with local distributors and strong relationships with hospitals and chemists.

Aurobindo Pharma’s gross profit stood at Rs 941.28 crore, up 9.36% y-o-y, while its operating profit rose 10.47% to Rs 541.51 crore. The company’s net profit stood at Rs 330.42 crore, up 11.44% y-o-y.

The company’s asset base continues to expand, with a cumulative growth of 16.19% y-o-y. Aurobindo Pharma’s cash and cash equivalents stood at Rs 2,345.51 crore as of the end of December 2024.

Commenting on the results, Aurobindo Pharma’s management said, “We are please with our performance in the month of December 2024, driven by our focused strategy to expand our presence in key markets and diversify our product portfolio. Our strong operational performance and strategic initiatives have enabled us to deliver robust growth in our top and bottom lines.”

The company plans to continue to invest in research and development, as well as expand its presence in key markets, including the United States, China, and Europe. With its strong financial performance and strategic growth initiatives, Aurobindo Pharma is well-positioned to achieve its long-term goals and continue to be a leading player in the Indian pharmaceutical industry.

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Ruchika Sharma is a Correspondent for the Business Section at Medical Dialogue, a prominent online publication. She joined the organization in 2019 and has been covering various updates in the pharmaceutical, policy, insurance, business healthcare, medical news, pharma news, and healthcare investment sectors ever since. Ruchika’s background is in commerce, having earned a Bachelor’s degree in Commerce (B.Com) from Delhi University. She further pursued a post-graduate degree in Commerce (M.Com) after completing her undergraduate studies.

As a Correspondent for Medical Dialogue, Ruchika is responsible for reporting on the latest developments in the pharmaceutical industry, policy initiatives, insurance, and business-related healthcare news. Her coverage includes in-depth analysis of important news stories, market trends, and expert opinions from industry leaders and professionals. Her expertise lies in providing timely and accurate updates to readers, giving them valuable insights into the healthcare and pharmaceutical industry.

Ruchika can be reached through Medical Dialogue’s official email address, editorial@medicaldialogues.in. She can also be contacted via phone at 011-43720751. With her extensive knowledge in the field of commerce and her experience in reporting business news, Ruchika is well-equipped to provide readers with reliable and informative news coverage. Her dedication to delivering high-quality content has made her a trusted source for audiences seeking updates on the pharmaceutical and healthcare industry.

Overall, Ruchika’s expertise in the field of business and her extensive reporting experience make her an ideal contact for readers seeking credible information on the latest developments in the world of pharmaceuticals, healthcare, and insurance. Her availability at editorial@medicaldialogues.in and 011-43720751 ensures that readers can stay connected and informed about the latest news and trends in the industry.

Aurobindo Pharma, a generic drug manufacturer, has been ordered to pay over ₹155 crore in penalties, interest, and GST to the Central Government. The Additional Commissioner of Central Tax, Ranga Reddy GST Commissionerate, Hyderabad, passed the order for the period from 2017-18 to 2021-22. The order demands GST of ₹77.61 crore along with interest on the same amount. Additionally, a penalty of ₹77.61 crore has been imposed. The company has already paid ₹23.71 crore under protest and reversed input tax credit (ITC) of ₹8.78 crore, which was ordered to be used to pay the demand. The order was passed due to alleged irregularities, including excessive IGST refunds, non-surrender of IGST on short realization of export proceeds, and non-reversal of ITC. Aurobindo Pharma plans to appeal the order before the Appellate Authority. The company’s appeal will likely seek to contest the findings and potential adjustments made by the tax authority.

Amgen’s aflibercept and Aurobindo’s pegfilgrastim have received marketing authorization from the European Union (EU) for their respective products. Aflibercept, marketed as Eylea, is a vascular endothelial growth factor (VEGF) inhibitor used to treat certain types of macular degeneration and diabetic retinopathy. The EU approval is for the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) and diabetic retinopathy.

Pegfilgrastim, marketed as Neulasta, is a granulocyte-colony stimulating factor (G-CSF) used to reduce the risk of neutropenia (low white blood cell count) in patients receiving chemotherapy. The EU approval is for the treatment of neutropenia in adult patients receiving myelosuppressive chemotherapy.

The EU approval for both products was based on positive results from clinical trials. The aflibercept trial showed that the drug significantly improved visual acuity and reduced the risk of vision loss in patients with BRVO and diabetic retinopathy. The pegfilgrastim trial demonstrated that the drug reduced the incidence of febrile neutropenia (fever and low white blood cell count) in patients receiving chemotherapy.

The EU approval for both products is a significant milestone for Amgen and Aurobindo, as it allows them to market their products in the EU and make them available to patients in the region. The approval also provides a competitive advantage for both companies in the EU market, as they can now offer their products to patients and healthcare providers.

The approval of aflibercept and pegfilgrastim in the EU is also significant for patients with macular degeneration and diabetic retinopathy, as well as patients receiving chemotherapy. The availability of these products in the EU will provide patients with new treatment options and improve their quality of life.

In conclusion, the EU approval of Amgen’s aflibercept and Aurobindo’s pegfilgrastim is a significant milestone for both companies and a major breakthrough for patients with macular degeneration, diabetic retinopathy, and neutropenia. The approval provides a competitive advantage for both companies in the EU market and offers patients new treatment options and improved quality of life.

Aurobindo Pharma, a global pharmaceutical company, has received a positive opinion from the European Medicines Agency (EMA) for its biosimilar, Dyrupeg, which is a proposed biosimilar of the product Pegfilgrastim. This positive opinion is a significant milestone in the company’s journey to market its biosimilar product in the European Union (EU).

Dyrupeg is a proposed biosimilar of Pegfilgrastim, a protein designed to help reduce the toxicity and increase the effectiveness of chemotherapy in cancer patients. The drug works by stimulating the production of white blood cells, which helps to prevent neutropenia, a condition characterized by a low count of white blood cells.

The EMA’s positive opinion is based on a comprehensive review of the clinical and non-clinical data submitted by Aurobindo Pharma, including results from phase-III clinical trials. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the grant of a marketing authorization for Dyrupeg.

The company’s Biosimilar Dyrupeg is expected to be used to treat cancer patients undergoing chemotherapy, specifically those with non-myeloid malignancies, such as breast, lung, and gastrointestinal cancers. The biosimilar is designed to have similar efficacy and safety profile as the originator product, but at a more affordable price point.

Aurobindo Pharma has a strong track record of developing and commercializing complex generics and biosimilars. The company has a global presence, with a network of manufacturing facilities, R&D centers, and offices in over 60 countries. With this positive opinion from the EMA, Aurobindo Pharma is poised to bring its biosimilar, Dyrupeg, to the European market, providing more affordable treatment options for cancer patients.

The European Union is one of the largest and most complex regulatory environments for pharmaceutical companies, and obtaining a positive opinion from the EMA is a significant achievement. Aurobindo Pharma’s success in securing a positive opinion for Dyrupeg is a testament to its commitment to developing high-quality, affordable pharmaceutical products that meet the evolving needs of patients, healthcare providers, and payers.

Aurobindo Pharma, a leading Indian pharmaceutical company, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) related to its subsidiary’s API manufacturing facility in Telangana. The facility, owned and operated by Apitoria Pharma Pvt Ltd, was inspected by the USFDA from September 23 to September 27, 2024, and categorized under Voluntary Action Indicated (VAI).

The USFDA inspection at Unit 2 of Apitoria Pharma facility in Gaddapotharam village, Sanga Reddy district, resulted in two procedural observations, which Aurobindo Pharma has committed to resolve within the required timeline. According to Aurobindo Pharma’s statement, the company will take necessary measures to address these observations and maintain compliance with quality standards.

It is worth noting that Aurobindo Pharma, as one of the largest and leading Indian pharmaceutical companies, is well-positioned to benefit from the depreciating rupee. With a significant contribution to exports, the company is expected to reap benefits from the current currency trend.

The VAI classification reflects Aurobindo Pharma’s commitment to maintaining quality standards and staying in compliance with regulatory requirements. This classification highlights the company’s confidence in its manufacturing facilities and demonstrates its commitment to quality and compliance. Aurobindo Pharma has been proactively addressing the observations and will continue to ensure that its facilities meet international standards, thereby maintaining the trust of its customers and stakeholders.