# EDGAR Filing Document

**Accession Number:** 0001135951
**File Stem:** 0001575872-25-000721
**Filing Date:** 2025-11
**Character Count:** 13201
**Document Hash:** 93d4f040f48b04cf63b4e3634e5033d4
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001575872-25-000721.hdr.sgml**: 20251125

**ACCESSION NUMBER**: 0001575872-25-000721

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 5

**CONFORMED PERIOD OF REPORT**: 20251124

**FILED AS OF DATE**: 20251125

**DATE AS OF CHANGE**: 20251125

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** DR REDDYS LABORATORIES LTD
- **CENTRAL INDEX KEY:** 0001135951
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** K7
- **FISCAL YEAR END:** 0331

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-15182
- **FILM NUMBER:** 251514977

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 8-2-337, ROAD NO.3 BANJARA HILLS
- **CITY:** HYDERABAD
- **PROVINCE COUNTRY:** K7
- **ZIP:** 500-034
- **BUSINESS PHONE:** 91 40 49002900

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 8-2-337, ROAD NO.3 BANJARA HILLS
- **CITY:** HYDERABAD
- **PROVINCE COUNTRY:** K7
- **ZIP:** 500-034

#### <br>

#### SECURITIES AND EXCHANGE COMMISSION
**Washington, D.C. 20549**

Form 6-K

**REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16** 

#### UNDER THE SECURITIES EXCHANGE ACT OF 1934

# November, 2025

# Commission File Number 1-15182

#### DR. REDDY'S LABORATORIES LIMITED
(Translation of registrant's name into English)

**8-2-337, Road No. 3, Banjara Hills**

**Hyderabad, Telangana 500 034, India**

#### +91-40-49002900
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ⌧&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Form 40-F ◻

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ______

**Note:** Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______

**Note:** Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ◻&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; No ⌧

If "Yes" is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b): 82-________.

**EXHIBITS** 

---

| | |
|:---|:---|
| **Exhibit** <br>**Number** | **Description of Exhibits** |
| [99.1](rdy0823_ex99-1.htm) | [Intimation dated November 24, 2025](rdy0823_ex99-1.htm) |

---

**SIGNATURES** 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

---

| | | | |
|:---|:---|:---|:---|
|  | DR. REDDY'S LABORATORIES LIMITED <br>(Registrant) | DR. REDDY'S LABORATORIES LIMITED <br>(Registrant) | DR. REDDY'S LABORATORIES LIMITED <br>(Registrant) |
| Date: November 24, 2025  | By: | /s/ K Randhir Singh | /s/ K Randhir Singh |
|  |  | Name: | K Randhir Singh |
|  |  | Title: | Company Secretary |

---

## Exhibit 99.1

**Exhibit 99.1**

---

| | |
|:---|:---|
| ![](rdy0823_ex99-1img01.jpg) | **Dr. Reddy's Laboratories Ltd.**<br>8-2-337, Road No. 3, Banjara Hills<br>Hyderabad – 500 034, Telangana, India<br>CIN: L85195TG1984PLC004507<br>Tel:&nbsp;&nbsp;&nbsp;&nbsp; + 91 40 4900 2900<br>Fax:&nbsp;&nbsp;&nbsp;&nbsp; + 91 40 4900 2999<br>Email: <u>mail@drreddys.com</u><br>Web: <u>www.drreddys.com</u> |

---

November 24, 2025

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)

BSE Limited (Scrip Code: 500124)

New York Stock Exchange Inc. (Stock Code: RDY)

NSE IFSC Ltd. (Stock Code: DRREDDY)

Dear Sir/Madam,

---

| | |
|:---|:---|
| **Ref:** | **<u>Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015</u>** |

---

Please find enclosed a Press Release viz. "Dr. Reddy's receives European Commission approval for AVT03 (denosumab), a proposed Biosimilar of Prolia® and Xgeva®"

This is for your information and records.

Thanking you,

Yours faithfully,

For **Dr. Reddy's Laboratories Limited**<br>

![](rdy0823_ex99-1img02.jpg)

**K Randhir Singh**

*Company Secretary, Compliance Officer & Head-CSR*

![](rdy0823_ex99-1img03.jpg)<br>

---

| | | |
|:---|:---|:---|
| **DR. REDDY'S LABORATORIES LTD.** | **CONTACT** | **CONTACT** |
| 8-2-337, Road No. 3, Banjara Hills,  | **Investor relationS** | **Media relationS** |
| Hyderabad - 500034. Telangana, India. | Aishwarya Sitharam<br><u>aishwaryasitharam@drreddys.com</u> | priya K<br><u>PRIYAK@drreddys.com</u> |

---

**Dr. Reddy's receives European Commission Approval for AVT03 (denosumab), a Proposed Biosimilar of Prolia<sup>®</sup> and Xgeva<sup>®</sup>**

**Hyderabad India; November 24, 2025**– Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar of Prolia<sup>®</sup> (denosumab) and Xgeva<sup>®</sup> (denosumab).

Prolia<sup>®</sup> is a prescription medicine used to treat osteoporosis in women who have been through menopause and in men who are at increased risk of fractures, bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoid <sup>[1].</sup> Xgeva<sup>®</sup> is a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone <sup>[2].</sup>

The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in September 2025 and was based on a totality of evidence, including analytical comparisons, pharmacokinetic and pharmacodynamic data, and outcomes from a confirmatory clinical trial. The EC decision is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

In May 2024, Dr. Reddy's and Alvotech entered into a license and supply agreement for the commercialization of AVT03. Under the agreement, Alvotech will develop and manufacture AVT03, while Dr. Reddy's is responsible for registration and commercialization in applicable markets, including the U.S. and Europe. Dr. Reddy's commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the UK. Upon approval Dr. Reddy's will offer the biosimilar under the tradenames Acvybra<sup>®</sup> (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy<sup>®</sup> (denosumab) 70 mg/mL solution for injection in a vial.

**About AVT03**

AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia<sup>®</sup> and Xgeva<sup>®</sup>, which are both denosumab but in different presentations. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction<sup>[1]</sup>.

**References**

1. Amgen Inc. Prolia<sup>®</sup>(Denosumab): Prescribing Information. Downloaded from:

<u>https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf</u>

2. Amgen Inc. Xgeva<sup>®</sup> (Denosumab): Prescribing Information. Downloaded from:

<u>https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf</u> 

**Use of trademarks**

Prolia<sup>®</sup> and Xgeva<sup>®</sup> are registered trademarks of Amgen Inc.

**About Dr. Reddy's**: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance.

Over the last 25 years, our Biologics team has developed into a fully integrated organization with robust capabilities in the development, manufacture and commercialization of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 30 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across developed as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In 2024, we launched our first biosimilar in the United Kingdom, Versavo® (biosimilar bevacizumab). This follows our launch of pegfilgrastim in the U.S and Europe through our partner. Our biosimilars business has a key role to play in driving both near-term and long-term growth.

For more information, log on to: <u>www.drreddys.com.</u>

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2025. The company assumes no obligation to update any information contained herein.